The Top Line: Recent Episodes
Fierce Life Sciences
Biopharma and medtech explained. Every week, journalists from Fierce Biotech, Fierce Medtech, and Fierce Pharma recount the latest industry trends and why they matter. We'll analyze the week's biggest business news, from mergers and marketing to drug R&D and device development. Available every Friday morning.
The future of patient support may depend less on how much data organizations collect and more on how effectively they connect, govern and activate it. In this sponsored episode of The Top Line, host Stephanie Butler speaks with ZS principals Asheesh Shukla and Kirti Prakash about the changing role of patient data in life sciences and what it will take to support more personalized engagement at scale.
The conversation examines several shifts reshaping the industry, including the move from reactive care to proactive intervention, the growing role of AI-powered experiences and the increasing importance of trust, consent and compliance in patient engagement. As organizations invest in new technologies, the speakers contend that success will depend on creating connected data foundations that can deliver timely, actionable insights across the patient journey.
Listeners will hear practical guidance on structuring data for actionability, building AI-ready capabilities and designing governance models that support both innovation and accountability. The discussion closes with a look at where patient services may be headed next and why organizations that prepare now will be better positioned to improve patient experiences and outcomes in the years ahead.
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Novo Nordisk’s second-quarter earnings results this week were closely watched by analysts and investors eager to see whether the rollout of oral Wegovy could neutralize concerns about the pharma’s pipeline.
Fierce spoke to Novo’s chief financial officer, Karsten Munk Knudsen, to dig into the figures, including the reasons behind the company’s decision to raise its full-year guidance and the launch of oral Wegovy across Europe.
In the candid conversation, Knudsen also reflected on Novo’s “rollercoaster” journey in obesity, his approach to pursuing long-term growth for the company and why he’s “still optimistic” about CagriSema despite recent setbacks.
To learn more about the topics in this episode:
- Novo CEO accepts ‘couple of setbacks’ in R&D as CagriSema posts more mixed data
- Novo CEO has 'no doubt' on eventual share price recovery as Wegovy pill continues to wow
- ‘I’m a lot more optimistic today’: Mike Doustdar tells Fierce about pivotal first year as Novo Nordisk CEO
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The continued shift toward self-administered therapies is changing how pharmaceutical companies think about patient support. While access and affordability remain priorities, a growing share of industry attention is focused on the patient experience itself, particularly during the critical transition from prescription to successful treatment initiation.
In this episode of The Top Line, Adam Shain, Vice President and Head of Business Transformation and Growth and Government Affairs Lead at Noble, an Aptar Pharma company, examines why patient onboarding, device training, and engagement strategies are increasingly being viewed as interconnected components of a broader patient experience. Drawing from Noble's work in self-administration support, Shain discusses the importance of incorporating patient insights into program design, the evolving complexity of at-home treatment models, and the industry's growing focus on adherence and long-term treatment success.
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Is biotech taking a trip to the world of psychedelic drugs? Why is Novo Nordisk going after Eli Lilly’s Zepbound ads? And what are peptides?
This week on "The Top Line," Fierce's Zoey Becker, Will Maddox and Kevin Dunleavy chat about some of the biggest recent stories. From a psychedelics acquisition that could spark more movement in the emerging field to an advisory committee meeting on peptides shrouded in political controversy to a lawsuit between the two major obesity drugmakers, we’ll catch you up on the latest developments shaking up the biopharma world.
To learn more about the topics in this episode:
- ‘A rising tide scenario’: Why other Big Pharmas could follow Lilly into psychedelics
- UPDATE: Peptides favored on 1st day of closely watched FDA compounding adcomm
- Peptide adcomm Day 2: Emideltide voted down in panel's 1st pushback
- Novo Nordisk files lawsuit accusing rival Eli Lilly of running ‘false and misleading’ GLP-1 ads
- Novo escalates Lilly false advertising suit with planned bid to halt comparative ads
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This week on "The Top Line," Fierce Healthcare and Life Sciences' editor-in-chief steps behind the microphone for a solo episode highlighting several of the biggest stories in biopharma.
The episode covers GSK’s first lung cancer approval following its acquisition of Nuvalent, Axiom Biosciences’ unusual plan to list first in Hong Kong before pursuing a Nasdaq co-listing amid a resurgent biotech IPO market, and the U.S. House’s passage of legislation directing the FDA to update its animal testing rules.
The episode also includes an update from the Fierce newsroom, including the arrival of a new Fierce Biotech staff writer, and a reflection on why human judgment, curiosity and original reporting matter more than ever.
To learn more about the topics in this episode:
- GSK secures first lung cancer approval as FDA clears Jideytro in quick payoff from Nuvalent deal
- ‘There is always a first’: Why US biotech Axiom will begin its IPO journey in Hong Kong
- House passes bill directing FDA to update animal testing rules
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Clinical trial success depends on more than scientific rigor and operational execution. It also depends on the financial systems that support every stage of a study. In this episode of The Top Line, Zahiah “Zee Zee” Gueddar, senior director of commercial strategy for the Clinical Trial Financial Suite at IQVIA Technologies, discusses why modernizing clinical trial finance has become a strategic priority for sponsors.
As trials become more complex, fragmented systems and manual workflows are creating bottlenecks that limit visibility, delay payments and introduce unnecessary risk. Gueddar explains how these challenges affect site relationships, operational efficiency and study performance, and why organizations can no longer afford to treat finance as a disconnected administrative process.
The conversation also highlights key indicators of readiness for transformation, from cross-functional alignment to executive sponsorship, and outlines the common pain points study teams face today. Ultimately, success depends on moving toward a connected, transparent and predictable financial model that reduces friction, improves collaboration and supports faster, more reliable clinical trials.
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Boston. San Francisco. Beijing? The global biotech industry has long been concentrated in a handful of cities. But which emerging hubs could become dominant forces in biotech in the decades ahead?
In this week’s episode of “The Top Line,” Fierce Biotech’s Darren Incorvaia and Will Maddox discuss a new Fierce special report identifying five cities with the potential to become major forces in the global biotech industry. Did your favorite city make the cut? Listen to find out.
To learn more about the topics in this episode:
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Top emerging biotech hubs in 2026
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As US lawmakers increase scrutiny of Chinese trials, industry fears ‘huge distraction and expense’
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British biotech VC funding shows ‘signs of recovery,’ but IPO rebound yet to materialize
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Could Basel be the next Boston? How the Swiss biotech hub is quietly raising its game
This week's episode is sponsored by IQVIA Biotech.
Built for biotech innovators, IQVIA Biotech is a full-service CRO, designed for agility, fast decisions, and the urgency needed for emerging biopharma. With dedicated teams and deep therapeutic expertise, we help move programs forward with focus and confidence. Visit IQVIABiotech.com
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Medical affairs is at an inflection point. As science advances and healthcare professionals gain access to information in real time, medical teams face a mandate to deliver insight with greater speed, relevance and impact.
In this episode of The Top Line, Josh Schwartz, Vice President of Medical Affairs, North America at BeOne Medicines, and Jalpa Shah, who leads the medical and evidence practice at ZS Pharma discuss what a modern medical affairs model requires. The conversation explores how the function is becoming a more strategic business driver and why traditional measures of activity are no longer enough to demonstrate value.
The episode examines the structural challenges that continue to hold organizations back, including fragmented data systems, limited visibility into insights and the difficulty of translating engagement into measurable outcomes. It also looks at how artificial intelligence (AI) is reshaping workflows by helping teams generate insights faster, identify trends and inform next best actions.
The discussion also considers the capabilities, operating models and cultural shifts medical affairs teams will need to keep pace with science and influence clinical practice. The central takeaway is clear: Future success will depend less on access to more data and more on the ability to turn intelligence into coordinated action.
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AI is reshaping how organizations compete, but more data and more tools do not automatically lead to better decisions. In this episode of The Top Line, Justin Masterson, senior vice president of human sciences at The Directions Group, challenges leaders to look beyond AI adoption and focus on the discipline required to act on intelligence.
Masterson argues that the defining issue for many organizations is not a data problem, but a decision readiness problem. As information ecosystems become more complex, the ability to translate insight into timely, confident action is emerging as a critical business differentiator.
With more than 20 years of experience in healthcare and human sciences, Masterson shares perspective on how companies can align teams, processes and strategies to unlock AI’s value without becoming overwhelmed by the volume of available information.
For leaders navigating new technologies, competing priorities and higher expectations for speed, this conversation offers a practical reframing of where AI value is created. Learn why decision readiness may be the next true advantage.
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This week on "The Top Line," we’re covering some of the biggest stories across biopharma before turning to one of the industry’s major scientific meetings of the summer.
First, we discuss Vertex’s $10 billion acquisition of Crinetics Pharmaceuticals, the company’s largest deal to date, and what it says about Vertex’s push beyond its historic strength in cystic fibrosis. We also cover growing scrutiny from U.S. lawmakers over the industry’s use of clinical trials in China.
Then, Fierce Pharma Senior Editor Fraiser Kansteiner recounts his recent trip to New Orleans for the American Diabetes Association’s 2026 Scientific Sessions with Fierce Pharma Marketing’s Zoey Becker. For years, ADA has focused heavily on its eponymous indication, but this year’s meeting made clear how much the conversation is evolving, with obesity data from drugmakers of all stripes taking up more of the spotlight. Topics include the biggest data sets from the meeting, what it was like to sit down with Novo Nordisk’s new CEO for the first time and the latest from Insulet’s Marvel collaboration on a line of comics about an Omnipod-wearing superheroine.
To learn more about the topics in this episode:
- Vertex, in its largest-ever deal, acquires endocrine disease specialist Crinetics for $10B
- As US lawmakers increase scrutiny of Chinese trials, industry fears ‘huge distraction and expense’
- ‘I’m a lot more optimistic today’: Mike Doustdar tells Fierce about pivotal first year as Novo Nordisk CEO
- ADA: Lilly pulls back curtain on impressive triple-G efficacy in patients with obesity, diabetes
- ADA: Amgen highlights Repatha perks, GLP-1 pitfalls in push to boost cardiometabolic pedigree
- With ADA in the books, analyst says Lilly is ‘widening its lead’ in the obesity race
- ADA: Novo's Wegovy pill reaches new GLP-1 patients with impressive 3M prescription milestone
- ADA: Tolerability ‘not to be underappreciated’ in Roche, Zealand’s amylin obesity prospect
- ADA: Boehringer execs claim survodutide tolerability 'consistent' with class despite phase 3 update
- ADA: Lilly posts oral semaglutide-topping data as Foundayo speeds toward 2nd potential nod in diabetes
This week's episode is sponsored by IQVIA Biotech.
Built for biotech innovators, IQVIA Biotech is a full-service CRO, designed for agility, fast decisions, and the urgency needed for emerging biopharma. With dedicated teams and deep therapeutic expertise, we help move programs forward with focus and confidence. Visit IQVIABiotech.com
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Big Pharma dealmaking has picked up, but the biotech path to a signed agreement is still anything but simple.
In this episode, recorded at Fierce Biotech Week, Senior Editor James Waldron leads a discussion on the evolving BD&L landscape across pharma and biotech.
He is joined by Kaleem Chowdhury, Ph.D., CEO of Haiku Biosciences; Liz Leveille, who leads the Boston Innovation Hub and discovery transactions at Merck; and Abbas Kazemi, CEO of Nimbus Therapeutics.
The panel digs into the realities behind the headlines, from investor scrutiny and platform company pressure to China’s growing role in licensing and the long relationship-building that often happens before a deal gets done.
To learn more about the topics in this episode:
- March M&A surge triggers high expectations for 2026
- 'Biopharma ecosystem is back to full health,' fueled by M&A: PwC
- Facing mounting China licensing costs, biopharma buyers turn to AI and local know-how to keep up
- After 230% deal size explosion, China is no longer the 'bargain basement' for biopharma licensing: analyst
- Was Big Pharma’s ‘unusually aggressive’ M&A spree to blame for March IPO drought?
This week's episode is sponsored by IQVIA Biotech.
Built for biotech innovators, IQVIA Biotech is a full-service CRO, designed for agility, fast decisions, and the urgency needed for emerging biopharma. With dedicated teams and deep therapeutic expertise, we help move programs forward with focus and confidence. Visit IQVIABiotech.com
See omnystudio.com/listener for privacy information.
In this sponsored episode of The Top Line, host Stephanie Butler is joined by Sheila Plant, vice president of regulatory affairs at Allucent, to examine how FDA Breakthrough Therapy and RMAT designations can support more strategic oncology development.
Although both pathways are intended to speed development, they are not interchangeable. Plant outlines the key distinctions, noting that Breakthrough Therapy requires evidence of substantial improvement over existing treatments, while RMAT is available for regenerative medicine therapies and centers on preliminary clinical evidence indicating the potential to address unmet medical needs.
The conversation also explores the strategic choices that determine whether sponsors are ready to pursue these designations, from building a credible data package to designing trials with clinically meaningful endpoints and keeping manufacturing readiness aligned with development timelines.
Once a designation is granted, closer collaboration with the FDA can help sponsors navigate development with more dynamic feedback. But as Plant emphasizes, these pathways deliver the greatest value when they are part of a disciplined regulatory strategy.
Listen now to learn how sponsors can approach expedited pathways with greater clarity and position oncology programs for meaningful acceleration.
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In this episode of “The Top Line,” recorded on site at Fierce Biotech Week in Boston, Fierce’s Ayla Ellison sits down with Christelle Huguet, Ph.D., executive vice president and head of R&D at Ipsen, to discuss how the company is building its pipeline through external innovation while maintaining internal scientific accountability.
Huguet explains Ipsen’s approach to partnering, describing the company as an “accelerator” that helps move promising science from academic labs and biotech partners toward patients. She also discusses how Ipsen evaluates which programs move forward, why transparency with partners is essential from the start and what the company is watching as it heads into a year with several key clinical and regulatory milestones.
To learn more about the topics in this episode:
- Ipsen unveils data for Botox rival that drove long-acting anti-wrinkle jab into phase 3
- Ipsen scuttles liver disease candidates from $952M Albireo acquisition
This week's episode is sponsored by IQVIA Biotech.
Built for biotech innovators, IQVIA Biotech is a full-service CRO, designed for agility, fast decisions, and the urgency needed for emerging biopharma. With dedicated teams and deep therapeutic expertise, we help move programs forward with focus and confidence. Visit IQVIABiotech.com
See omnystudio.com/listener for privacy information.
In this sponsored episode of The Top Line, experts from Myriad Genetics join host Stephanie Butler to examine how tumor-informed molecular residual disease, or MRD, testing is beginning to redefine what early insight can mean in oncology drug development. As biomarker-driven therapies become more precise, the ability to understand response earlier and more clearly is increasingly being viewed as foundational to smarter development strategy.
The discussion looks at how ultrasensitive, tumor-informed MRD assays can help track response over time, potentially surface deeper signals earlier and inform decisions that shape trial design, patient selection and regulatory direction. It also considers why these capabilities may become more important as oncology programs face growing pressure to balance speed, flexibility and evidence generation.
Listeners will hear why early diagnostic strategy is increasingly seen as a competitive differentiator, how MRD can help teams make better decisions sooner and why its role in oncology development is expected to continue to evolve and expand.
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Each year, the global oncology community flocks to Chicago to convene at the American Society of Clinical Oncology’s annual meeting for a weekend of buzzy data drops, practice-changing posters and insightful sessions.
In this week’s episode of "The Top Line," Fierce Biotech and Fierce Pharma’s Darren Incorvaia, Zoey Becker and Angus Liu break down the biggest takeaways from their weekend of reporting live from the Windy City. From “nutty” in vivo CAR-T data to a historic first for a Chinese biotech asset, ASCO 2026 reflected new and continuing trends within the evolving state of cancer care today.
To learn more about the topics in this episode:
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ASCO: Revolution Medicines confident in RAS leadership as rivals square up
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ASCO: Lilly exec points to ‘nutty’ 100% response rate for in vivo CAR-T as justifying Kelonia buyout
- ASCO preview: With expectations jacked up, Akeso's ivonescimab to face scrutiny in high-stakes plenary
This week's episode is sponsored by IQVIA Biotech.
Built for biotech innovators, IQVIA Biotech is a full-service CRO, designed for agility, fast decisions, and the urgency needed for emerging biopharma. With dedicated teams and deep therapeutic expertise, we help move programs forward with focus and confidence. Visit IQVIABiotech.com
See omnystudio.com/listener for privacy information.
High‑risk MDS and AML continue to challenge clinicians, with limited durable responses and few options for older or treatment‑refractory patients. In this sponsored episode of The Top Line, host Stephanie Butler is joined by Dr. Amer Zeidan, Professor of Internal Medicine at Yale School of Medicine, to unpack new ASCO 2026 data that are drawing attention across the myeloid malignancies field.
The discussion focuses on mesutoclax, a novel oral BCL‑2 inhibitor evaluated in combination with azacitidine. Dr. Zeidan breaks down early findings showing a 100% objective response rate with CR rate of 40% per IWG 2006 criteria and 90% composite complete response with CR in 60% in treatment‑naïve high‑risk MDS, along with strong efficacy and encouraging safety signals in AML, with over 80% composite CR, and with potent activity in TP53 mutant, as well as zero death within 30 or 60 days and rapid cytopenia recovery.
Listeners will hear how mesutoclax’s potency, selectivity, and pharmacokinetic profile may overcome key limitations of existing BCL‑2 inhibitors, and what these results could mean for future frontline treatment strategies.
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Boston remains biotech's most influential hub, but the questions facing the region are increasingly global.
Recorded live at Fierce Biotech Week in Boston, this panel discussion brings together Uli Stilz, senior advisor at Flagship Pioneering; Bruce Beutel, CEO and co-founder of PassKey; and Ben Bradford, head of external affairs at MassBio, for a conversation about the future of biotech innovation. Moderated by Senior Writer Darren Incorvaia, the discussion explores everything from funding pressures and talent trends to AI, clinical development and growing competition from biotech ecosystems around the world.
Along the way, the panelists debate what the industry can learn from China's rapid innovation model, why investors and pharma companies have shifted toward clinically validated assets and whether biotech needs a fundamentally new operating model to accelerate drug development and bring breakthrough science to patients.
To learn more about the topics in this episode:
- After 230% deal size explosion, China is no longer the 'bargain basement' for biopharma licensing: analyst
- Facing mounting China licensing costs, biopharma buyers turn to AI and local know-how to keep up
- As calls for COINS Act expansion grow, will new rules sweep up China biotech licensing?
- From drug development to M&A, Big Pharmas showcase AI’s ‘measurable impact’
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Direct-to-patient models are no longer an experiment - they're becoming a critical part of the modern prescription journey. In this sponsored episode of The Top Line, host Kelly Hogan talks with Jeremy Richardson, chief commercial officer at GiftHealth, about how DTP is redefining access, transparency and speed in pharma commercialization.
Richardson shares insights from more than a decade in specialty pharmacy and explains where the traditional model breaks down for patients and providers. He addresses common misconceptions about DTP, including the belief that it only works for cash-pay or consumer-driven drugs, and outlines how a single, seamless platform can support medications across therapeutic areas and price points.
With experience guiding more than 7 million patients through their prescription journeys, Richardson discusses what manufacturers truly need from a DTP partner, how technology can accelerate time to therapy and why ease and transparency are becoming nonnegotiable expectations. He also looks ahead to where the prescription journey is headed - and what pharma commercial leaders must do now to keep pace.
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Recorded last week at Fierce Biotech Week in Boston, this episode of “The Top Line” features a conversation with Kristen Fortney, Ph.D., co-founder and CEO of BioAge Labs.
In a conversation with Ayla Ellison, editor-in-chief of Fierce Healthcare and Life Sciences, Fortney discusses the company’s decade-long effort to use human aging data to identify drug targets tied to longevity and age-related disease. She also breaks down BioAge’s oral NLRP3 inhibitor, BGE-102, which the company believes could have applications across cardiovascular, ocular and CNS diseases by targeting inflammation linked to aging biology.
The conversation also explores why pharma companies are paying closer attention to aging and exercise biology, how GLP-1 drugs are reshaping conversations around prevention and what the future of aging-related medicine could look like.
To learn more about the topics in this episode:
- BioAge CEO has big plans for 'multi-disease impact' of NLRP3 drug across cardio, ocular and CNS
- Novartis, BioAge take on age-related diseases in $550M pact
- What can we learn from 2024’s biotech IPOs?
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Emerging pharma organizations face unique technology challenges as they prepare for launch. Expectations for AI-enabled decision-making continue to rise, even as teams remain small and operate in highly regulated environments. In this sponsored episode of The Top Line, Fierce Biotech host Kelly Hogan speaks with JR Raelin, executive director of analytics and insight at SynOx Therapeutics and Krishna GS, business technology solutions manager at ZS, about how first-launch and emerging companies can design an agentic future-ready technology road map.
The conversation examines common pitfalls, including chasing new technology and AI trends before establishing data readiness, underinvesting in integration, and relying on fragmented point solutions. Raelin and Krishna explain why strong data foundations, governance, and interoperability are prerequisites for. and how agentic AI—when built on that foundation—can close the gap between insight and action in real commercial workflows.
Listeners will also hear a framework for scaling platforms over time, guidance on what effective implementation looks like in the first 60 to 90 days, and examples of connected workflows across commercial, medical, and patient functions. The episode closes with a compelling case for why the agentic roadmap is the most important strategic asset a first-launch company builds before its second product—and how getting it right converts a single launch into a portfolio intelligence engine.
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Despite a prolonged period of policy uncertainty in the U.S.—and the ripple effects across the global life sciences and healthcare industries—executives at health companies are still seeing opportunities amid the tumult. In many cases, they’re finding that the resilient business models they built through disruptions like the pandemic have positioned their companies not just to survive, but to thrive in a new normal for the industry.
In this episode of “The Top Line,” Fierce Pharma’s Fraiser Kansteiner chats with Glenn Hunzinger, PwC’s U.S. health industries leader, about results from the firm’s recent survey on investor sentiment. Focusing on health companies, Hunzinger explains how many innovative drugmakers have managed to capitalize on the shifting environment. Still, he warns that a more uncertain landscape for U.S. innovation and continued tariff pressures on sectors such as medtech could pose challenges down the line.
To learn more about the topics in this episode:
- AstraZeneca CEO's conservative MFN model excludes reference markets from forecast
- As Johnson & Johnson navigates changing tariff landscape, execs lay out their expectations
- Trump eyes 100% tariff rate for companies that have not struck MFN deals: Bloomberg
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After months of mixed messaging from the White House, the pharmaceutical industry has gained more clarity on the second Trump administration’s import tariff policy for drugs. While many of the industry’s biggest firms have navigated the trade threat through investment pledges and drug pricing deals, the current landscape remains murkier for small- and mid-sized drugmakers.
In this episode of “The Top Line,” Fierce Pharma’s Fraiser Kansteiner sits down with Chris Young, a principal in KPMG’s trade and customs practice, to discuss the pharma tariff landscape following President Donald Trump’s announcement in early April of a potential 100% tariff on imported drugs. Young explains how the policy could affect smaller drugmakers that haven’t inked high-profile pricing deals with the government and shares best practices for navigating the rapidly evolving U.S. trade environment.
To learn more about the topics in this episode:
- An update on the pharma industry’s reshoring effort
- Trump eyes 100% tariff rate for companies that have not struck MFN deals: Bloomberg
- Trump's tariff threats, measured by manufacturing
- UK signs off on US pharma deal, ensuring tariff reprieve as Britain aims to reattract investments
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In this sponsored episode of The Top Line, host Kelly Hogan speaks with Dr. Bettine Boltres, director of scientific affairs, integrated systems at West Pharmaceutical Services, about the development of the West Synchrony prefillable syringe system. As drug pipelines grow and regulatory expectations increase, pharma and biotech companies face mounting pressure to reduce complexity while accelerating development timelines.
Dr. Boltres explains how West Synchrony addresses these challenges by offering a fully integrated system rather than a collection of individual components. By providing complete design verification data, system level specifications and a single global regulatory package, West enables developers to eliminate redundant testing, streamline submissions and move more quickly into clinical fill.
The discussion highlights the benefits of single supplier accountability, improved supply security and reduced risk across development and commercialization. Designed for biologics and modern vaccines, West Synchrony sets a new standard in prefillable syringe systems.
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Theranostics is transforming cancer care, but scaling these treatments requires overcoming operational and workforce challenges. In this episode of The Top Line, Curium’s Mike Patterson discusses how access, safety and trust are shaping the next phase of growth for targeted radiopharmaceutical therapies.
Patterson explains why strong coordination across ordering, manufacturing and distribution is essential to delivering therapies on time. He also explores how building trust with physicians, care teams and patients requires education, consistent communication and reliable support at every stage of the treatment process.
As theranostics expands into community settings, new challenges are emerging. Workforce shortages, training needs and the importance of standardized practices are key considerations for scaling safely. Patterson shares how industry collaboration can help address these gaps while maintaining high standards of care.
He also outlines a future defined by greater access, reduced travel burdens and a more seamless patient experience. Listen to the full episode to learn how Curium is working to make theranostics more accessible across the United States.
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It’s a pivotal year for RNA therapeutics pioneer Ionis Pharmaceuticals.
After transitioning from a partnering model to a full-ownership strategy following the 2024 approval of Tryngolza, the company is expecting an FDA decision to expand the drug into severe hypertriglyceridemia as its first non-rare-disease indication for a wholly owned product. Meanwhile, potentially game-changing phase 3 readouts are expected from Ionis’ Novartis-partnered lipoprotein(a) candidate and AstraZeneca-partnered ATTR cardiomyopathy program.
In this week’s episode of "The Top Line," Fierce’s Angus Liu interviews Ionis CEO Brett Monia, Ph.D. He discusses the science of antisense oligonucleotides, the significance of the two closely watched upcoming clinical readouts, and what it takes to turn a 30-year-old discovery platform into a full-fledged commercial biotech.
To learn more about the topics in this episode:
- Ionis slashes Tryngolza's price tag by 93% ahead of anticipated label expansion
- 'It’s going to be huge': The 'diabolical' molecule poised to become biotech's next gold rush
- AstraZeneca sets sights on 25+ blockbusters by 2030 to fuel $80B revenue ambition
- As questions swirl around ATTR competition, Alnylam plots path to market leadership for Amvuttra
- Ionis exec shares method to the Madness after 2026 Drug Name Tournament win
- Ionis plots FDA filing after rare neurological disease candidate posts phase 3 win
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Speed, precision, and visibility are critical to clinical trial success, and logistics plays a central role in delivering all three. In this interview, Manishaa O’Brien, director of commercial operations at Marken UPS Healthcare Precision Logistics, shares how the Laboratory Advantage service line is helping central labs and sponsors accelerate timelines while maintaining sample integrity and compliance.
O’Brien discusses how Marken’s global network, combined with its air and ground fleet, connects clinical sites worldwide and expands access to diverse patient populations. She explains how enhanced tracking, integrated data systems and a 99.5% on-time performance rate support reliable, end-to-end visibility for lab partners. Dedicated account management and tailored logistics solutions further strengthen collaboration and help ensure regulatory requirements are met.
The conversation also explores key trends shaping the future of clinical trial logistics, including increasing complexity, the rise of AI-driven routing and the growing importance of sustainability. From automation to eco-friendly packaging innovations, Marken is building a more efficient and resilient supply chain. Watch the full interview to learn how these advancements are helping clinical trials move faster and smarter.
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President Donald Trump has struck a deal with the UK that exempts prescription drugs imported to the United States from tariffs for three years. In exchange, Britain’s National Health Service will pay 25% more for new drugs. The question now is: Can the U.S. negotiate similar deals with other countries?
In this week’s episode of "The Top Line," we examine the drug pricing agreement between the UK and the U.S. Fierce Pharma’s Kevin Dunleavy explores the issue with Jeffrey Gerrish, who served as deputy U.S. trade representative for Asia, Europe and the Middle East during the first Trump administration.
They break down the specifics of the UK-U.S. partnership and whether the deal could be applied to other countries to bring drug prices more in line with those in the U.S. They also discuss Trump’s other attempts to use America’s economic power to secure drug pricing agreements.
To learn more about the topics in this episode:
- UK signs off on US pharma deal, ensuring tariff reprieve as Britain aims to reattract investments
- Merck executes its own Brexit, moving all R&D operations out of UK
- AstraZeneca's Soriot is considering move of stock listing to the US: Times
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Biomarkers are playing an increasingly critical role in shaping the future of oncology trials—and the pace of innovation is accelerating. In this sponsored episode of The Top Line, host Stephanie Butler sits down with Dr. Danielly Vicente, Associate Medical Director of Oncology and Hematology at Allucent, to explore how advanced biomarker strategies are transforming clinical development.
From improving patient selection in early-phase trials to enabling adaptive study designs, biomarkers are helping researchers identify the right patients, optimize outcomes, and reduce development risks. Dr. Vicente discusses how approaches like comprehensive genomic profiling, basket and umbrella trials, and real-time monitoring are driving more efficient and successful oncology programs.
The episode also tackles the challenges of integrating genomic testing and biomarker screening into trials, including operational complexity and data coordination. Plus, learn how emerging technologies such as circulating tumor DNA (ctDNA) and multiomic strategies are set to redefine trial design and accelerate precision medicine.
Tune in to hear how biomarker-driven innovation is advancing oncology research—and what it means for the future of patient care.
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Artificial intelligence is increasingly shaping how pharma companies approach content strategy and decision-making. In this episode of The Top Line, Kristen Pilkiewicz, EVP and executive creative director at Sound Healthcare Communications, examines how AI is being applied in real-world marketing workflows.
Rather than positioning AI as a standalone solution, Sound has integrated it into core processes to support faster content development, more rigorous strategy testing and improved alignment with regulatory expectations. Pilkiewicz outlines how the company is building tools tailored to pharma and training teams to use AI as a partner in decision-making.
The discussion also explores PerspectiveX, an AI-powered decision intelligence platform that simulates health care provider reactions to content before it reaches market research. By helping teams refine messaging earlier, the tool aims to reduce bias, improve research inputs and strengthen overall campaign performance.
For health care marketers and industry stakeholders, the conversation offers a grounded perspective on how AI is evolving from experimentation to practical application across the communications landscape.
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Spray-dried dispersions are widely used, but they do not always deliver expected results. In this sponsored episode of The Top Line, host Stephanie Butler speaks with AustinPx Chief Scientific Officer Dr. Dave Miller about how drug developers can recover from suboptimal formulations and manufacturing challenges.
Miller outlines common issues, including poor bioperformance, inefficient scale-up, intellectual property limitations and high pill burden. He explains how next-generation amorphous solid dispersion technologies, such as KinetiSol, expand formulation design space, remove solvent constraints and support more efficient, scalable manufacturing.
The conversation also covers how to introduce improved formulations into late-stage clinical programs and navigate regulatory considerations. Miller shares how teams can accelerate timelines while maintaining product quality and performance.
For developers looking to optimize assets or reduce risk, this episode delivers clear, expert insight. Listen to the full interview to learn how to overcome formulation challenges and advance drug development.
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China’s biotech rise has been a persistent concern for federal health leaders, Congress, and many biopharma executives. But to Roivant CEO Matt Gline, the country is nothing more than a red herring.
In this week’s episode of "The Top Line," Fierce Biotech’s Darren Incorvaia chats with Gline about China, artificial intelligence and the exciting year ahead for Roivant’s lead asset brepocitinib.
To learn more about the topics in this episode:
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After 230% deal size explosion, China is no longer the 'bargain basement' for biopharma licensing: analyst
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NIH grant cuts hit women, early-career scientists the hardest: analysis
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Roche pumps $480M into South Korea biopharma industry to establish global trial 'ecosystem'
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Lilly pledges $500M to South Korea biopharma industry, following Roche’s lead
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Pfizer-backed Priovant scores again with fast-rising brepocitinib in midstage study
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The wait is over. Fierce Biotech has released its annual ranking of the top 10 pharma R&D budgets of 2025—offering a clear look at which companies are spending the most on innovation and how those investments are shifting year over year.
In this week’s episode of "The Top Line," Darren Incorvaia and Eric Sagonowsky break down the new report, digging into who claimed the top spot, which companies moved up or down the rankings and whether any newcomers broke into the top 10.
The conversation also explores the broader trends behind the budgets—what increased R&D investment signals about pipeline priorities, where companies may be pulling back and whether this year’s list reflects continued momentum or a plateau after several years of elevated spending.
Listen to the full episode for a closer look at how the industry’s biggest players are allocating their R&D budgets—and what it could mean for the next wave of drug development.
To learn more about the topics in this episode:
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The top 10 pharma R&D budgets of 2025
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Biopharma R&D pipeline shrinks for 1st time in 30 years: report
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After a wave of high-profile pledges to bring pharmaceutical manufacturing back to the United States, a clearer picture of what reshoring actually looks like is starting to emerge. Tens of billions of dollars have been committed to new U.S. plants, but those investments are unlikely to translate into immediate gains in domestic production.
In this week’s episode of "The Top Line," Fierce’s Eric Sagonowsky sits down with Rosemary Coates, executive director of the Reshoring Institute, to unpack where the trend stands today and what comes next. Coates explains why the pharma industry is uniquely positioned to bring supply chains back to the U.S., and the challenges companies face as they try to do it.
To learn more about the topics in this episode:
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UCB unveils plan to build $2B biologics plant near its US headquarters in Atlanta
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Pharmas have promised $370B in US investments amid 2025's onshoring boom: DPR
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Global pharma manufacturing output surged in '25 in 'front-loading' response to US tariff threats: report
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While Lilly’s position in the obesity market and wider GLP-1 space has remained largely unshakeable in recent months, a crack in the company’s armor may be forming, according to at least one analyst. As that assessment dealt a blow to the company’s stock price in recent weeks, Lilly is plowing forward all the same with more details on its next wave of potential incretin drugs.
In this week’s episode of "The Top Line," the Fierce Pharma team breaks down Lilly’s recent HSBC downgrade, what it signals for the GLP-1 and obesity markets, and the data shaping the company’s next wave of diabetes and weight loss products. Fierce’s Eric Sagonowsky is joined by Kevin Dunleavy and Fraiser Kansteiner to unpack the latest and assess the commercial narrative around GLP-1s so far.
To learn more about the topics in this episode:
- With downgrade, HSBC casts doubt about Lilly's 'stairway to heaven' trajectory
- Lilly's triple-G bet lowers blood sugar, prompts 16.8% weight loss in phase 3 diabetes trial
- Lilly's obesity triple threat smashes efficacy expectations in phase 3 but proves intolerable for some
- Novo’s CagriSema tops semaglutide in ph. 3 diabetes study
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In this episode of The Top Line, host Chris Hayden speaks with Olive McCormick, Head of Quality and Qualified Person at Almac Clinical Services about why late‑breaking issues in clinical trials pose such significant risk — and what teams can do to prevent them. McCormick explains that operational misalignment, delayed communication, overlooked regulatory steps or misinterpretation of requirements under the new UK Clinical Trial Regulation can snowball quickly, putting both patient safety and organizational credibility at stake.
She and Hayden discuss how sponsors, CROs and site teams can keep trials on track by establishing strong communication channels and maintaining a unified understanding of responsibilities as studies reach key milestones. McCormick stresses the value of proactive engagement and early insight into potential challenges, noting that waiting too long to identify or resolve issues increases the likelihood of disruptions.
The episode calls on clinical research professionals to prioritize transparency, coordination and shared accountability. Whether you’re leading a trial or supporting one, the discussion offers practical guidance to help teams avoid the preventable setbacks that so often arise near the finish line.
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Since Xaira’s eye-popping $1 billion fundraise in 2024, the company has said relatively little in public. That’s made it one of biotech’s more closely watched black boxes: a company with enormous backing, enormous ambition and, until recently, few clues about what it has actually been building.
In this week’s episode of “The Top Line,” Fierce Biotech’s Gabrielle Masson speaks with Xaira Chief Operating Officer Jeff Jonker about what the AI company is uncovering. Jonker discusses Xaira’s strategy as a next-generation biotech, the modalities and disease areas it is exploring, what he expects the industry to look like over the next five years and why Xaira is going after the “high-hanging fruit.”
To learn more about the topics in this episode:
- Xaira exec divulges R&D focus, how $1B fundraise fuels AI-driven hunt for what the 'industry is hungriest for'
- New AI drug discovery powerhouse Xaira rises with $1B in funding
- Biotech's top money raisers of 2024
See omnystudio.com/listener for privacy information.
In this week’s episode of “The Top Line,” we take a deep dive into the fourth-quarter performance of the biopharma industry and how the sector fared in 2025 overall.
As the world’s 25 largest biopharma companies reported earnings, attention quickly shifted to their outlook for 2026. Only five drugmakers expect faster growth than in 2025, and some are projecting sales declines.
One of the most surprising outlooks came from Novo Nordisk, which expects a significant drop in sales. Several other companies are also facing the loss of patent protection for blockbuster drugs, leading them to forecast either declining revenue or slower growth.
Fierce Pharma’s Kevin Dunleavy and Eric Sagonowsky discuss the trends emerging from fourth-quarter earnings and how the industry’s performance compares with previous quarters. They also examine the intensifying GLP-1 competition between Novo Nordisk and Eli Lilly and how the two companies appear to be heading in opposite directions.
To learn more about the topics in this episode:
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- Eli Lilly, Novo Nordisk lead revenue boom in the 'always tricky' Q4
- As Lilly flourishes in Q4, peer projections signal looming sector slowdown in 2026
- Biopharma industry gathers momentum in Q3
- In Q3, drugmakers saw a marked decline in US vaccine sales as Eli Lilly kicked into higher gear
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The design of the modern R&D lab may be due for a rethink.
Artificial intelligence and automation are reshaping how science gets done, yet many of the physical spaces where research happens were built around assumptions that date back decades.
In this episode of “The Top Line,” Fierce Life Sciences & Healthcare Editor-in-Chief Ayla Ellison speaks with Gensler Global Sciences Practice Area Leader Ryley Poblete about how automation, data and new research workflows are influencing lab design. As computational scientists, engineers and automated systems become more central to research teams, organizations are reconsidering how labs should be structured to support both focused work and collaboration across disciplines.
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Physiology connects genes and molecules to whole-body function, shaping every stage of drug discovery and development. In this sponsored episode of The Top Line, Sue Bodine, president-elect of the American Physiological Society and a professor at the Oklahoma Medical Research Foundation, explains why physiology remains central to biomedical innovation.
Bodine details how physiology strengthens biotech and pharmaceutical research by clarifying how therapies behave in complex biological systems, identifying unintended effects and supporting stronger regulatory narratives. She also examines the expanding role of physiology in wearable technology, remote patient monitoring and artificial intelligence, where biological context is essential to turning large data sets into clinically meaningful insights.
The episode also highlights the society’s campaign, “Physiology: The Science Life Depends On,” aimed at elevating awareness of foundational science amid funding uncertainty. For executives, investors and health care leaders seeking sustainable innovation and patient impact, this discussion underscores a clear message: Breakthroughs depend on physiology. Listen to the full interview.
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For more than a decade, CAR-T therapy has been the miracle of oncology, turning end-stage blood cancers into curable diseases. But the application of these engineered cell therapies is expanding to reset the immune system for patients living with lupus, stiff person syndrome and other autoimmune conditions. And with new frontiers come new rules.
In this week’s episode of "The Top Line," Fierce Pharma’s Angus Liu chats with Harpreet Singh, M.D., chief medical officer at Precision for Medicine and a former director of the FDA's Division of Oncology, about a recent article by FDA officials led by CBER Director Vinay Prasad, M.D., laying out the agency’s perspective on its regulation of autoimmune CAR-T therapies. Singh discusses how the agency’s "case-by-case" approach, as indicated in the article, could be similar to—and different from—CAR-T for oncology indications. She also talks about how drug developers should follow existing development experience, as well as prepare for specific requirements for long-term patient follow-up and potential new clinical endpoints from the agency.
To learn more about the topics in this episode:
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FDA signals tailored approach to ‘carefully shepherd’ CAR-T therapy for autoimmune diseases
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Kyverna gains clear view to first CAR-T approval for autoimmune disease after 'truly remarkable' SPS readout
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Cabaletta CAR-T wipes out B cells without preconditioning in small autoimmune trial
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What does the future hold for sterile fill-finish CDMOs in a rapidly evolving market?
In this sponsored episode of The Top Line, Denis Johnson, CEO of Grand River Aseptic Manufacturing, discusses the capacity crunch facing U.S. sterile manufacturing and what it means for healthcare stakeholders. As acquisitions reduce available capacity, Annex 1 drives preference for isolator technology, and companies reshore production, competition for specialized sterile fill expertise is intensifying.
Johnson explains why segmentation and specialization are becoming critical differentiators in the CDMO space, particularly as biologics pipelines expand and product launches accelerate. He also shares how GRAM is investing in new facilities, high-volume syringe and cartridge capabilities, and workforce development to stay ahead of client demand while maintaining compliance and flexibility.
For B2B healthcare professionals, marketers and payers seeking clarity on supply chain resilience and manufacturing strategy, this episode delivers timely insight. Listen now to explore how leading CDMOs are preparing for the next wave of sterile manufacturing demand.
See omnystudio.com/listener for privacy information.
Though uncertainty still surrounds the Trump administration’s pharmaceutical import tariffs, the trade rhetoric set off a clear response across the industry in 2025. Drugmakers accelerated U.S. manufacturing plans, pushing production higher as companies looked to insulate their supply chains. Now, with many of those moves already underway, that breakneck pace is expected to level off through 2026 and 2027, according to a recent outlook from Atradius.
In this week’s episode of "The Top Line," Fierce Pharma’s Fraiser Kansteiner speaks with Brady McKinney, an underwriter for Atradius' pharmaceuticals sector focusing on the Americas, about the credit insurer's recent industry report. McKinney explains how tariff concerns drove last year’s manufacturing surge and why Atradius expects a period of stabilization ahead. He also discusses how companies are weighing the risk of future trade flare-ups and what that could mean for production, investment and credit conditions across the sector.
To learn more about the topics in this episode:
- Global pharma manufacturing output surged in '25 in 'front-loading' response to US tariff threats: report
- FDA emphasizes drug ingredients, production pledges as it debuts PreCheck manufacturing program
- In quick reversal, Trump calls off tariff threat related to Greenland pursuit
- 3 biopharma CEOs explain why they are 'authentically optimistic' for 2026
See omnystudio.com/listener for privacy information.
Biopharmaceutical innovation is advancing at an unprecedented pace, yet many patients still face barriers to accessing new medicines. In this episode of Health Matters, John O’Brien, president and CEO of the National Pharmaceutical Council, speaks with Kristin Cahill about why policy, pricing and benefit design are increasingly shaping whether innovation reaches patients.
O’Brien shares insights from his career spanning pharmaceutical companies, health plans and government, including his time as a senior drug pricing advisor during the first Trump administration. He explains why prescription drugs remain a focal point in cost debates, what policymakers often misunderstand about value, and how middlemen and misaligned incentives affect what patients pay at the pharmacy counter.
The conversation also examines emerging approaches such as direct-to-patient models, most-favored-nation pricing and the early effects of the Inflation Reduction Act, highlighting potential benefits as well as risks to access and future innovation. For healthcare professionals, payers and marketers seeking clarity in a complex policy environment, this episode offers a grounded perspective on how to ensure medical breakthroughs translate into meaningful patient benefit. Listen to the full interview.
See omnystudio.com/listener for privacy information.
Every clinical setback carries lessons. That’s why Fierce revisits major trial failures each year: not to dwell on disappointment, but to understand what went wrong and what it signals for the road ahead.
The 2025 edition of Fierce Biotech’s clinical trial flops report highlights a familiar pattern. Large drugmakers account for a disproportionate share of high-profile misses, reflecting the reality that many of the industry’s most ambitious late-stage programs now sit inside big pharma portfolios.
On this episode of "The Top Line," Fierce Biotech's James Waldron and Fierce Pharma's Fraiser Kansteiner discuss the failures that stood out in 2025 and what they suggest about the challenges facing drug development.
To learn more about the topics in this episode:
- 2025's top 10 clinical trial flops
- Sanofi ousts Paul Hudson after 'bumpy ride,' enlists Merck KGaA CEO to lead the French pharma
See omnystudio.com/listener for privacy information.
Community oncology is playing an increasingly important role in how cancer care is delivered across the United States, with a growing share of patients treated outside large academic medical centers. In this sponsored episode of The Top Line, host Chris Hayden sits down with Kirk Kaminsky, executive vice president and group president of North American Pharmaceutical Services for McKesson, to examine what this shift means for patients, providers and the industry.
Kaminsky explains how advances in cancer science have transformed many diagnoses into long-term conditions, increasing the need for accessible, high-quality care in local communities. He discusses the challenges community practices face as innovation accelerates, including evolving reimbursement models, operational pressures and the adoption of new technologies.
The conversation also explores the role of community oncology in expanding access to clinical trials and accelerating research, as well as how artificial intelligence is being used to improve both clinical and administrative workflows. Kaminsky shares his outlook on the next five to 10 years of cancer care and why supporting community oncology will be critical to continued progress. Listen to the full interview to learn more.
See omnystudio.com/listener for privacy information.
The leaders of this year’s list of the most anticipated drug launches will likely come as no surprise: Fierce’s annual report on the biggest potential launches of 2026 details how the next obesity meds from Novo Nordisk and Eli Lilly are expected to rake in a respective $17.2 billion and $11.8 billion in annual sales by 2032, so long as they score their expected approvals this year.
Elsewhere in the report are candidates from the likes of Gilead Sciences, Johnson & Johnson, AstraZeneca and other biopharmas big and small, spanning a range of indications from breast cancer to essential tremor. All together, predicted 2032 sales for the year’s top 10 weigh in at nearly $46 billion.
In this week’s episode of “The Top Line,” Fierce’s Andrea Park and Gabrielle Masson dive into the report, mapping out how it stacks up against last year’s edition and digging into the enormous sales potential of the top two drugs on the list.
To learn more about the topics in this episode:
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Top 10 most anticipated drug launches of 2026
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Novo Nordisk stock crashes after CagriSema misses phase 3 weight-loss goal
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Lilly's obesity pill largely maintains weight lost on injectable GLP-1s
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Top 10 most anticipated drug launches of 2025
See omnystudio.com/listener for privacy information.
Please see the following USPI, US ISI, EU SmPC and Canadian Product Monograph for complete LIVMARLI product information:
US Important Safety Information (https://livmarli.com/important-safety-information/)
US Prescribing Information (https://files.mirumpharma.com/livmarli/livmarli-prescribinginformation.pdf?_ga=2.264585739.54248471…
EU SmPC (https://ec.europa.eu/health/documents/community-register/html/h1704.htm)
Canadian Product Monograph (https://files.mirumpharma.com/livmarli/livmarli-product-monograph-en.pdf)
Learn more about the latest research for Mirum’s investigational therapies: MRM-3379 (https://mirumpharma.com/wp-content/uploads/2025/09/FXS-NDD-2025-Mouse-Model-Poster_FINAL.pdf), volixibat in PSC (https://s29.q4cdn.com/633867992/files/doc_presentations/2024/Jun/Mirum-VISTAS-and-VANTAGE-Interim-Analysis-Results-Presentation.pdf) and PBC (https://mirumpharma.com/wp-content/uploads/2025/05/Heneghan-M-EASL-2025-VANTAGE-28-week-data-with-volixibat-in-PBC.pdf), and brelovitug (https://www.natap.org/2025/AASLD/AASLD_22.htm). LIVMARLI is also currently being evaluated in the Phase 3 EXPAND study (https://clinicaltrials.gov/study/NCT06553768) in additional settings of cholestatic pruritus.
References
- What is hepatitis delta? Hepatitis B Foundation. Accessed January 14, 2026. https://www.hepb.org/research-and-programs/hepdeltaconnect/what-is-hepatitis-delta/
- Agarwal K, Jucov A, Dobryanska M, et al. Brelovitug (BJT-778) monotherapy achieved 100% virologic response in patients with chronic hepatitis D: on treatment week 48 phase 2 study results. Presented at: AASLD 2025; November 7-11, 2025; Washington, D.C.
- Sagnelli C, Sagnelli E, Russo A, Pisaturo M, Occhiello L, Coppola N. HBV/HDV co-infection: epidemiological and clinical changes, recent knowledge and future challenges. Life (Basel). 2021;11(2):169. doi:10.3390/life11020169
- Negro F, Lok AS. Hepatitis D: a review. JAMA. 2023;330(24):2376-2387. doi:10.1001/jama.2023.23242
- Hunter J, Rivero-Arias O, Angelov A, Kim E, Fotheringham I, Leal J. Epidemiology of fragile X syndrome: A systematic review and meta‐analysis. doi:10.1002/ajmg.a.36511
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Artificial intelligence is reshaping medical communications, but it is not a substitute for human judgment. In this episode of The Top Line, experts from RTI Health Solutions explore how AI is being used across scientific writing, editing and information discovery—and why guardrails are essential.
The conversation examines practical applications of AI, including literature screening, early-stage drafting and editorial support, while addressing the limitations that can undermine quality and trust. Panelists share real-world examples showing how different tools can produce conflicting results and why expert review is required to ensure accuracy and relevance.
Listen to the full interview to gain insight into how organizations can harness AI’s efficiency while keeping scientific rigor and the human perspective at the center of their work.
See omnystudio.com/listener for privacy information.
In this week’s episode of “The Top Line,” Fierce checks in with professional services juggernaut KPMG on the biopharma rebound many industry watchers predicted in the closing months of 2025.
Fierce Pharma’s Fraiser Kansteiner sits down with Kristin Cirello Pothier, principal and U.S. and Americas region life sciences sector leader, as well as global deal advisory and strategy leader for health and life sciences at KPMG, to discuss the firm’s latest industry outlook. Pothier also explains how drugmakers are cutting through the noise and reflects on the technology, indication and valuation factors shaping today’s dealmaking appetite.
To learn more about the topics in this episode:
- 2026 forecast: After a surge of M&A in Q4, will the trend continue?
- Halozyme catches M&A wave to snap up Surf Bio in delivery tech deal worth up to $400M
- Global pharma manufacturing output surged in '25 in 'front-loading' response to US tariff threats: report
- In quick reversal, Trump calls off tariff threat related to Greenland pursuit
See omnystudio.com/listener for privacy information.
With this year’s iteration of the J.P. Morgan Healthcare Conference in the rearview mirror, the biopharma industry has officially closed the door on 2025 as it heads into what is sure to be another eventful year.
In this week’s episode of "The Top Line," Fierce Pharma's Zoey Becker sits down with Angus Liu and Fierce Biotech's Gabrielle Masson to unpack the key topics and trends that stood out at this year's conference in San Francisco. The conversation offers an early look at the themes and questions that could shape the year ahead.
To learn more about the topics in this episode:
- All the meetings, none of the megadeals: Is JPM's purpose evolving?
- JPM26: What’s in a biopharma? CEO says Teva has the goods
- JPM26: Astellas CEO resists 'rescue BD' as $6B Xtandi patent cliff nears
See omnystudio.com/listener for privacy information.
As payers focus on long-term outcomes and real-world performance, value matters more than ever. RTI Health Solutions experts discuss how clear evidence storytelling drives access decisions.
See omnystudio.com/listener for privacy information.
In early 2025, the FDA was rocked by sweeping layoffs and leadership turnover, raising questions about whether the agency could maintain its pace in reviewing new drug applications.
By the end of the year, the approval picture told a more complicated story, with momentum building after a slow start.
This week on "The Top Line," we dig into what the numbers really show, which companies and therapies came out on top, and what the FDA’s performance over the course of 2025 signals for the drug review process going forward.
To learn more about the topics in this episode:
- 2025 drug approvals: Despite FDA tumult and macro uncertainty, biopharma scored with 55 new products
- 2024 drug approvals: Small companies loom large with several key FDA nods
- 2023 drug approvals: After a down year, FDA signs off on a bounty of new meds, including 7 from Pfizer
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What does it really mean to put patients first in today’s life sciences landscape? In this sponsored episode of The Top Line, leaders from RTI Health Solutions explore how patient voices are transforming evidence generation, market access and medical communication. From patient-reported outcomes and advisory boards to inclusive value storytelling and trust-building across diverse communities, the discussion highlights why patient-centric strategies are no longer optional—and how they can influence approval, reimbursement and real-world impact.
See omnystudio.com/listener for privacy information.
As artificial intelligence continues to dominate conversations across life sciences, many companies are reaching an inflection point between experimentation and real-world impact. In a recent episode of The Top Line, Mark Sullivan, president of regulated industries at Salesforce, said the industry is moving past broad promises toward a clearer divide between organizations that have laid the groundwork for AI and those still struggling to operationalize it. While early pilots have delivered mixed results, Sullivan said the next phase will be defined by how effectively companies use AI to augment their workforce, not replace it. Much like laptops or smartphones, AI proficiency is quickly becoming a baseline expectation for professionals, shaping productivity, decision-making and resilience across drug development, manufacturing and commercialization.
Sullivan emphasized that success with AI agents hinges on trust, governance and high-quality data—particularly in an industry where accuracy and compliance are nonnegotiable. Life sciences organizations are beginning to see value in agents that support patient engagement, clinical trial matching and commercial execution, but only when those agents are grounded in enterprise data and clear guardrails. With as much as 80% of industry data unstructured, he said, the process of deploying agents often exposes deeper data and architecture challenges that must be addressed. Companies that solve for these issues can unlock both efficiency and growth, using AI not just to cut costs, but to strengthen patient relationships and drive innovation. The conversation offers a practical look at how life sciences leaders can move beyond the hype and build an agentic strategy that delivers measurable results—making it a must-listen for anyone navigating AI adoption in a regulated environment.
See omnystudio.com/listener for privacy information.
China has moved from a fast-following biotech market to a source of globally competitive innovation, according to Josh Smiley, president and chief operating officer of Zai Lab. Speaking on The Top Line podcast, Smiley traces the country’s evolution over the past two decades, pointing to regulatory harmonization, expanded national insurance coverage and deepening R&D capabilities as key drivers. He said the most recent wave of Chinese biotechs is no longer focused solely on domestic opportunities but on first- or best-in-class medicines that can compete worldwide, particularly in oncology and immunology.
Smiley also details how Zai Lab blends China’s patient access and development speed with global clinical and regulatory standards, a model he says has helped accelerate programs such as Zai’s DLL3-targeted antibody-drug conjugate for small cell lung cancer into late-stage trials. As China-sourced deals now account for a growing share of global biotech partnerships, Smiley argues companies that integrate China early — without treating it as a standalone market — will have a strategic edge. The conversation offers a candid look at what’s next for Zai Lab and why China’s expanding role in drug innovation is likely to reshape the global pipeline for years to come.
See omnystudio.com/listener for privacy information.
After a turbulent 2025, the biopharma industry is heading into the new year with major questions still unresolved.
A tough biotech investing environment, aggressive direct-to-consumer drug marketing and sweeping U.S. policy changes reshaped the landscape last year. Many of those pressures are expected to persist into 2026, even as early signs point to a thaw in venture capital. At the same time, the industry is testing whether DTC drug sales can meaningfully affect pricing for patients and whether broad manufacturing onshoring goals can realistically apply to advanced therapies like cell and gene treatments and radiopharmaceuticals.
In this week’s episode of "The Top Line," Fierce Pharma’s Fraiser Kansteiner sits down with three biopharma CEOs to unpack what defined 2025 and what comes next. He’s joined by Thijs Spoor, CEO of Perspective Therapeutics; Brian Culley, CEO of Lineage Cell Therapeutics; and Rich Daly, CEO of Catalyst Pharmaceuticals.
Together, they tackle issues from DTC sales and onshore manufacturing to drug pricing, regulatory uncertainty at the FDA and the broader innovations the leaders are most excited about this year.
To learn more about the topics in this episode:
- 2026 forecast: After a surge of M&A in Q4, will the trend continue?
- Editor's Corner: Fierce Biotech's 10 most-read stories of 2025
- What a year: Here are the stories that captivated our audience in 2025
- Editor's Corner: The top 10 Fierce Pharma Marketing stories of 2025
- 2026 forecast: Pharma clicks with patients as direct sales model shifts marketing strategies
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As 2025 closes, biopharma and healthcare are learning to live on shifting ground. In this special year-end episode of "The Top Line," Fierce reporters take stock of a year defined by federal research cuts, vaccine policy fights and leadership churn at the FDA, then push the conversation forward into the questions that will shape 2026. The through line is that uncertainty has become an operating environment, and the industry is recalibrating in real time.
Fierce Biotech’s Gabrielle Masson, joined by Darren Incorvia, traces how funding decisions can narrow the pipeline years before the consequences are visible. Fierce Pharma’s Fraiser Kansteiner sits down with Angus Liu and Eric Sagonowsky to unpack the new center of gravity inside federal agencies, where vaccine recommendations, review norms and new FDA pilots are colliding with questions about capacity and outside influence. From there, Ben Adams and James Waldron bring the lens to Europe, where Jefferies in London captured a cautiously optimistic market still wrestling with tariffs, pricing pressure and investment hesitation. The episode closes with Fierce Healthcare’s Heather Landi and Paige Minemyer sharing their outlook on 2026, from the fight over ACA subsidies and Medicaid headwinds to the next phase of AI adoption, where the promise is real but the payoff may be slower, messier and more uneven than the hype suggests.
To learn more about the topics in this episode:
- 'Unprecedented turmoil' engulfing FDA threatens public health: mRNA coalition speaks out
- FDA names Tracy Beth Høeg, fresh from vaccine safety probe, as acting head of drug center
- A dozen former FDA commissioners blast Prasad's proposed vaccine policy changes
- In letter to Makary, biotech CEOs push for FDA stability and say volatility threatens US innovation
- NIH grant cuts have disrupted hundreds of clinical trials, study finds
- 'Alternative history' of the NIH shows how a 40% budget cut may thwart new medicines
- House passes healthcare affordability bill without subsidy extension
- AMA: A look at concentration in commercial insurance, MA markets
- 2025 Outlook: Hospital finances show signs of stability, but rising costs will be a major headwind
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Walgreens is emerging as a real-world evidence partner for the biopharma industry, according to a new episode of The Top Line, sponsored by Walgreens. In the conversation, Deepak Kuletha, who leads data management and analytics for the company’s biopharma services division, explains how Walgreens’ 9 million daily interactions and nationwide footprint generate rich insights into patient behavior, access barriers and therapy performance in the real world. Kuletha shares examples of how Walgreens helps pharma partners optimize drug launches, identify early adoption patterns, uncover affordability challenges and improve patient support programs—ultimately enabling faster, evidence-based decision-making.
As real-world evidence grows more complex, Kuletha highlights how Walgreens’ advanced data management, privacy safeguards and emerging analytics tools—including machine learning and AI—help cut through the noise. These capabilities allow the pharmacy chain to synthesize de-identified data into actionable insights that reveal adherence risks, surface gaps in treatment understanding, and support earlier interventions. For life sciences professionals looking to understand how retail pharmacies are shaping the future of evidence generation, the episode offers a compelling inside look at the collaboration opportunities ahead. Listen to the full conversation to hear how Walgreens is turning scale into smarter, proactive patient care.
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Uncertainty reigned early this year with the inauguration of President Donald Trump and his threats to impose tariffs and slash prescription drug prices. But as players in the biopharma industry have gotten a better handle on the impact of these measures and the overall investment landscape, valuations have become more predictable and dealmakers have focused on larger, lower-risk acquisitions. The recent trends bode well for the business development landscape in 2026 and beyond.
In this week’s episode of “The Top Line,” Arda Ural, EY Americas life sciences sector leader, joins Fierce Pharma’s Kevin Dunleavy to discuss the dealmaking landscape in the biopharma industry. They dig into the Federal Trade Commission’s scrutiny of M&A transactions, revitalized therapeutic areas, artificial intelligence investment and the emergence of China as an innovation powerhouse.
To learn more about the topics in this episode:
- 2025 M&A up in value and deal count after year of 'conservatism and recovery': Leerink Partners
- After a 'reset' year for M&A, expect bigger deals in 2025: reports
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In this episode of Health Matters, GCI Health’s Ryan Kuresman and Health@WPP’s Wendy Lund explore the fast-shifting landscape of cancer care with Pam Traxel of the American Cancer Society Cancer Action Network. Traxel outlines the growing complexity facing patients—from navigating an expanding range of treatment options to managing rising costs.
The conversation also examines the evolving role of patient advocacy and the partnerships needed to drive meaningful change. Traxel emphasizes the importance of integrating lived experiences into policy, improving the credibility of patient-facing communication and strengthening early, ongoing collaboration between biopharma, policymakers and advocacy organizations. For healthcare and life sciences professionals seeking deeper insight into how access, innovation and policy must intersect to improve patient outcomes, this is a must-listen episode.
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Research shows that women remain woefully underrepresented at the highest levels of leadership in the life sciences industry. Those who have broken through that glass ceiling, however, are not only doing groundbreaking work in pharma, biotech, medtech and beyond but also reframing what it means to be a leader in the sector—as evidenced by the often-unconventional career paths and management philosophies of the 10 women featured in this year’s Fiercest Women in Life Sciences report.
In this week’s episode of “The Top Line,” Fierce’s Andrea Park and Gabrielle Masson dive into the report, highlighting several honorees’ paradigm-busting approaches to leadership, mentorship and building inclusive teams.
To learn more about the topics in this episode:
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2025's Fiercest Women in Life Sciences
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4 reasons life sciences still fail women at the top, despite a female-majority workforce: report
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GSK's Emma Walmsley to step down as CEO in shock move, giving way to commercial lead Luke Miels
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Merck KGaA, grappling with geopolitical tensions, reveals CEO transition
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Takeda taps Julie Kim to take over for retiring CEO Christophe Weber
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Bayer is reshaping its pharmaceutical business with a new operating model designed to enhance collaboration and bring research & development and commercialization closer together. In a recent episode of The Top Line podcast, Bayer executives Christine Roth, Executive Vice President and Head of Global Product Strategy and Commercialization, and Dr. Yesmean Wahdan, Head of Medical Affairs for the United States and North America, discussed how the company’s Dynamic Shared Ownership framework is driving faster innovation and helping accelerate the development of new therapies for patients. The model removes traditional hierarchies, empowers cross-functional teams and encourages real-time collaboration across departments.
Roth and Wahdan said the approach has already shortened regulatory timelines, reduced resource use and helped deliver treatments to patients sooner. By embedding commercial insights early in the research process, Bayer teams can anticipate market needs and focus on the greatest areas of unmet medical demand. The leaders said the company’s collaborative culture keeps patient benefit at the center of decision-making. To learn more about how Bayer’s model is transforming its pipeline, listen to the full episode of The Top Line.
See more from Bayer’s Christine Roth and Dr. Yesmean Wahdan on their LinkedIn profiles below:
Christine: https://www.linkedin.com/in/christine-roth-34b07b18/
Yesmean: https://www.linkedin.com/in/yesmean-h-wahdan-md-71409b199/
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In this episode of The Top Line, Fierce’s Chris Hayden speaks with Foresight Diagnostics co-founders Dr. Jake Chabon and Dr. Max Diehn about how their company is delivering the next generation of minimal residual disease (MRD) detection in cancer care.
Born from research at Stanford University, Foresight’s PhasED-Seq technology delivers ultra-sensitive detection—down to parts per ten million—enabling clinicians to identify microscopic traces of cancer that traditional imaging misses. The discussion explores how Foresight’s MRD platform, CLARITY, can have the ability to support more confident decision-making, from determining curative success in early-stage cancers to guiding consolidation treatment in lymphoma.
Chabon and Diehn highlight the company’s biopharma collaborations, clinical trial integration, and evidence-driven approach to guideline inclusion. They also look ahead to a future where MRD testing becomes central to oncology surveillance, accelerating therapy approvals and complementing genomic and digital pathology tools to advance precision medicine.
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In this week’s episode of "The Top Line," we take a deep dive into the top-line performance of the biopharma industry in the third quarter.
After a slow start to the year, U.S. drugmakers in particular have recovered, led by Eli Lilly. We examine which companies are hot and which are not. We also look at trends that emerged in the third quarter, such as the shortfall in vaccine sales, especially in the U.S., and companies’ sales projections for the rest of the year.
Fierce Pharma’s Kevin Dunleavy and Eric Sagonowsky discuss their observations from the third quarter and put the industry’s performance in perspective compared with previous quarters. They also examine the biopharma outlook for the fourth quarter.
To learn more about the topics in this episode:
- Q1 biopharma layoff trends, plus expectations for Q2
- 7 top pharmas posted revenue declines in Q1. The common thread? All are US firms
- Several US pharma giants stage Q2 sales turnaround after subpar results earlier in year
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As the prospect of import tariffs and drug price reform marshals billions of biopharma investment dollars into the U.S., the feasibility of rapid domestic manufacturing buildouts could hinge on a new program cooking at the FDA. How that program, dubbed PreCheck, will work in practice—and on what timeline—are key questions as the U.S. looks to bolster its local pharmaceutical production base.
This week on “The Top Line,” we dive into comments from a recent public meeting on the industry’s hopes for PreCheck, which is being designed to streamline the process by which new biopharma manufacturing facilities are built in the U.S.
Fierce Pharma’s Fraiser Kansteiner sits down with Christopher Shilling, chief regulatory officer at gene therapy CDMO Forge Biologics—who attended the meeting—to offer an on-the-ground perspective and explore the aspects of the plan that could have the biggest impact on manufacturers. Shilling also outlines what he sees as FDA’s next steps, plus regulatory considerations that could most benefit CDMOs and the broader industry.
To learn more about the topics in this episode:
- Amid tariff-fueled onshoring push, Trump signs order to boost US stockpiling of certain drug ingredients
- FDA launches generics pilot program, advances facility PreCheck proposal in bid to incentivize US drug manufacturing
- Amid pharma's US investment spree, FDA unveils new program to streamline domestic plant build-outs
- Trump signs executive order to boost US drug manufacturing amid threat of tariffs
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The healthcare marketing landscape is evolving fast — shaped by regulatory shifts, patient empowerment, and the rise of digital health marketplaces. In this episode of The Top Line, sponsored by Havas Media Network, host Chris Hayden sits down with Holly Dunn, Managing Partner of Performance at Havas Media Network, to explore how pharma brands can redefine patient engagement for a more connected, equitable future.
Dunn explains how first-party data, AI-driven intent signals, and curated health marketplaces are enabling more compliant, transparent, and human-centered campaigns. She also discusses the growing role of healthcare creators, the fight against misinformation, and strategies to ensure high-quality, privacy-safe engagement across the patient journey.
If you’re in pharma or biotech marketing, this conversation offers critical insight into how leading brands are building trust and equity in an increasingly complex environment.
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Welcome to the Fierce Biotech Graveyard, our annual ritual remembering the biotechs we lost in 2025 and those on the brink.
In this episode, Fierce Biotech’s Darren Incorvaia and Gabrielle Masson came together to chat about themes from this year’s graveyard, including a cell therapy mausoleum, some mad science, and Darren’s incredibly dated reference to a novelty song from 1958.
To learn more about the topics in this episode:
- The 2025 Biotech Graveyard
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This week's episode of "The Top Line" features a discussion about what’s working now in biotech and what isn't.
Recorded Oct. 7 at Fierce Biotech Week, this panel featuring leaders from past Fierce 15 winners digs into timelines, partnerships, what's hype, what's signal and how teams are pressure-testing their models in today's market.
You'll hear from Generate Biomedicines CEO Mike Nally, Arbor Biotechnologies Chief Scientific Officer John Murphy, Epicrispr Biotechnologies CEO Amber Salzman, Ph.D., and Parabilis Medicines Chief Business Officer Greg Miller. The conversation was moderated by Fierce Biotech's Gabrielle Masson.
To learn more about the topics in this episode:
- Fierce Biotech's 2022 Fierce 15
- Fierce Biotech's 2023 Fierce 15
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Life sciences organizations are facing both intense pressure and extraordinary opportunity, according to Mark Sullivan, president of regulated industries at Salesforce. In a conversation with The Top Line’s Chris Hayden, Sullivan said companies too often operate in “survival mode,” focused on defending margins rather than leading innovation. But with the rise of AI and agentic technologies, he said, the industry is poised for a transformation that could reshape how drugs are developed, trials conducted and patient data used — all at greater speed and lower cost.
Sullivan emphasized that this new era requires rethinking how companies engage with stakeholders. Instead of distant, one-way interactions, he said, agentic AI enables dynamic, conversational relationships that improve satisfaction and generate actionable insights. Salesforce, he noted, is expanding beyond its CRM roots to help life science enterprises become “agentic” organizations — integrating secure, compliant AI systems across finance, HR and supply chains. With data security and trust at the core, Sullivan called on leaders to look beyond software replacement and pursue true digital transformation for the good of patients and the industry alike.
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The FDA made waves in early September when it announced a plan to publicly release complete response letters (CRLs) at the same time they are issued to sponsoring companies, part of what the agency calls a push toward “radical transparency.”
At the same time, the FDA released 89 new CRLs, adding to the more than 200 that were previously made public in July and shedding more light on the agency’s often opaque review process. That earlier document dump, though, only included rejection letters for drugs that were eventually approved. Now, for the first time, the agency is releasing CRLs for unapproved drug candidates—including recent high-profile rejections such as Ultragenyx’s gene therapy for Sanfilippo syndrome type A, Capricor Therapeutics’ Duchenne muscular dystrophy cell therapy and Replimune’s melanoma drug.
Publicly airing the rationale for rejecting drug candidates is a significant shift for the FDA and a potential cause for concern for the biopharma industry.
To unpack what the new policy means for drug developers, Fierce Biotech’s Darren Incorvaia sat down with Torrey Cope, a lawyer with Sidley Austin who represents and advises life sciences companies on issues related to the FDA.
To learn more about the topics in this episode:
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FDA releases ‘initial batch’ of more than 200 drug rejection letters
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FDA moves to publish drug rejection letters in real time, releases new batch including Replimune's high-profile snub
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FDA misinterpreted efficacy data that prompted DMD rejection, Capricor claims
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‘Weak’ evidence and an ‘unpleasant’ odor: FDA sheds light on drug refusal process
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'Several concerning observations': FDA sheds more light on reasons it rejected drugs
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With a new president of U.S. pharma at the helm—and two key FDA approvals now in the books—Boehringer Ingelheim is sharpening its focus on the lucrative American market.
In this week’s episode of “The Top Line,” we dive into Boehringer Ingelheim’s latest regulatory successes, two crucial launches, and the German company’s expanding commercialization push in the U.S.
Fierce Pharma’s Fraiser Kansteiner sits down with Brian Hilberdink—who joined Boehringer as president of U.S. human pharma in February—to discuss his game plan to further unlock the American market and capitalize on key BI green lights in idiopathic pulmonary fibrosis and lung cancer.
To learn more about the topics in this episode:
- Boehringer Ingelheim breaks into oncology with FDA approval for lung cancer med Hernexeos
- Boehringer Ingelheim breathes new life into lung fibrosis field with FDA approval for Jascayd
- 'Crossing fingers': Boehringer awaits key FDA decisions to spearhead 'maturing' pipeline
- Chutes & Ladders—Boehringer snatches up LEO exec for US pharma team
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Artificial intelligence is reshaping drug safety, but governance is just as critical as innovation, according to Marie Flanagan of IQVIA Safety Technologies. Speaking on The Top Line podcast, Flanagan said responsibility for AI in healthcare must be shared across compliance, technology, business teams and regulators. Strong governance, she said, ensures AI systems are ethically designed, technically validated, transparent and adaptable to continuous oversight.
Organizations can prepare by grounding their strategies in guiding principles such as human oversight, fairness and accountability, Flanagan said. She emphasized the need to embed governance in AI design from the start, rather than adding controls later. Compliance teams, she added, can shift from being seen as barriers to acting as enablers of safe innovation. From constant monitoring to feedback loops, the conversation highlights practical steps for managing AI in life sciences. Hear the full episode of The Top Line for a deeper look at how companies can balance innovation and responsibility.
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Tariffs, drug pricing reform, a government shutdown and a major turnover at one of the world’s largest drugmakers all converged this week, leaving plenty to unpack for the industry as it heads into fall. Greater clarity on President Donald Trump’s tariff and pricing strategies has likely come as something of a relief for those companies operating in the U.S., but that news was tempered by a shutdown of the federal government on Wednesday. Meanwhile, big changes are likely on the way at GSK, whose longtime CEO Emma Walmsley is headed for the exit.
In this week’s episode of "The Top Line," we break down some of the biggest stories across Fierce Pharma for the week—which may very well be some of the biggest stories of the year—touching on critical policy updates in the U.S., the furloughing of federal employees at agencies like the FDA and NIH and the imminent departure of GSK’s chief executive. Fierce Life Sciences’ Ben Adams sits down with Fierce Pharma's Fraiser Kansteiner to discuss the latest headlines and go over the key points from each major development that has played out.
To learn more about the topics in this episode:
- FDA avoids the worst amid government shutdown, but new applications put on hold
- NIH research grinds to a halt as government shuts down
- Pfizer offers price concessions, $70B US outlay in Trump's 'most favored nation' push
- Trump's pharma tariffs on hold amid administration's effort to secure pricing concessions, industry investment: Stat
- GSK's Emma Walmsley to step down as CEO in shock move, giving way to commercial lead Luke Miels
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Despite a challenging year, the biotech industry has continued to push boundaries, taking bold risks in pursuit of groundbreaking science. If anything, this year has only strengthened our conviction in the rising stars leading the next wave of innovation.
Fierce Biotech’s Fierce 15 class of 2025 is defined by their resilience, diversity in both strategy and leadership, and treatments that hold life-changing potential for underserved patients around the world.
In this week’s episode of "The Top Line," Fierce Biotech’s Gabrielle Masson and Fierce Pharma’s Andrea Park discuss what went into picking this year’s winners and some highlights from the special report.
To learn more about the topics in this episode:
- Introducing Fierce Biotech's 2025 Fierce 15
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Trust in pharma has always been fragile, and the rise of misinformation has made it even more precarious.
In this episode of "The Top Line," recorded at Fierce Pharma Week in Philadelphia, Freda Lewis-Hall, M.D., joins us to share how she has worked to put a human face on the industry. A psychiatrist, longtime patient advocate and former Pfizer chief medical officer, she explains why listening must come before messaging, how AI and omnichannel outreach can help or harm patient trust and why rebuilding credibility starts one conversation at a time.
To learn more about the topics in this episode:
- TV ads close to overtaking doctors as consumers' primary source for learning about new meds: survey
- Pharma's reputation is stable-ish. Will that survive Trump 2.0?
- ABPI finds familiarity breeds trust, supporting push for industry-healthcare collaborations
- Doctor Mike calls on healthcare, pharma leaders to lean into social media to rebuild trust with patients
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Robert Abel, chief scientific officer at Schrödinger, says advanced computational tools are changing the pace and accuracy of drug discovery. In a recent episode of The Top Line podcast, Abel outlined three areas where AI and machine learning are making the greatest impact: understanding disease biology, predicting protein structures and designing drug molecules. Schrödinger’s platform uses physics-based simulations alongside AI to evaluate millions of molecules in days, compared with the thousands traditionally synthesized in a year.
Abel pointed to real-world results, including a program that reached a clinical trial candidate in just 10 months — far faster than industry averages. He said the technology also helps overcome challenges such as improving drug selectivity and reducing the need for animal testing, aligning with FDA priorities. Abel will share more insights during his upcoming talk at AAPS PharmSci 360 in San Antonio this November. His session abstract is available here. To hear more about Schrödinger’s work in computational drug discovery, listen to the full interview.
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With Pfizer discontinuing Beqvez and BioMarin scaling back the commercial focus of Roctavian, the curative promise of hemophilia gene therapies is tempered by significant barriers that discourage widespread adoption.
In this week’s episode of “The Top Line,” Fierce Pharma’s Zoey Becker speaks with Glenn Pierce, M.D., Ph.D., vice president of medical at the World Federation of Hemophilia, about the complexities behind these innovative therapies and the multifaceted reasons for their slow uptake. Pierce discusses the competitiveness of the current hemophilia gene therapy market, why Pfizer’s product couldn’t keep up, and the patient populations that risk being left behind.
To learn more about the topics in this episode:
- As Pfizer backs out of hemophilia gene therapy space, CSL hopes Hemgenix is here to stay
- Pfizer discontinues hemophilia treatment Beqvez, emptying its gene therapy portfolio
- BioMarin downsizes Roctavian efforts but keeps hemophilia gene therapy for 3 markets
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Hope, when applied with purpose and action, can be a powerful force for driving change in healthcare.
That’s the philosophy of Eugene Woods, CEO of Advocate Health and a 2025 Fierce 50 honoree, who joins Ayla Ellison, Editor-in-Chief of Fierce Life Sciences & Healthcare, to share how he puts “Applied Hope” into practice. Woods explains how this approach combines optimism with action and why it’s become a guiding strategy for one of the nation’s largest nonprofit health systems.
In their conversation, Woods discusses leading through massive organizational change, cultural transformation and the rapid adoption of new technologies. He offers insights on improving quality and affordability, investing in both rural communities and urban neighborhoods and preparing for a future shaped by AI and more human-centered healthcare delivery.
To learn more about the topics in this episode:
Fierce 50 of 2025
Eugene A. Woods—Fierce 50 Leadership Honoree
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In the latest episode of the Health Matters podcast, former Food and Drug Administration Commissioner Scott Gottlieb joins WPP’s Wendy Lund, GCI Health’s Ryan Kuresman and Burson’s Judy Stecker to discuss the forces reshaping U.S. health policy. Gottlieb warns that while new laws such as the Inflation Reduction Act may lower government spending on drugs, consumers are unlikely to see significant relief at the pharmacy counter. Insurers’ tighter formularies and higher cost-sharing requirements, he said, could continue to drive affordability challenges for patients.
The discussion also covers the future of direct-to-consumer advertising, FDA’s role in combating health misinformation and the promise of cell and gene therapies. Gottlieb shares both caution and optimism — noting the risk of consumer frustration if policy changes fail to deliver savings, while pointing to breakthroughs that are transforming treatment and outcomes. To hear his full take on the challenges and opportunities facing health care leaders, listen to the full Health Matters episode.
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After many U.S. biopharma companies posted sales declines in the first quarter, the domestic pharma industry largely bounced back to growth in the second quarter.
In this episode of "The Top Line," Fierce Pharma's Eric Sagonowsky and Kevin Dunleavy break down the numbers behind the industry’s second-quarter performance.
Among U.S. pharma heavyweights, J&J, AbbVie, Pfizer, Regeneron, Bristol Myers Squibb and Biogen each eked out gains this past quarter. Their results varied, with individual stories worth highlighting at each of these major companies.
Beyond earnings, Sagonowsky and Dunleavy also discuss the growing competition in diabetes and obesity treatments between Eli Lilly and Novo Nordisk, as well as Merck’s rising financial reliance on its blockbuster cancer drug Keytruda, among other topics.
To learn more about the topics in this episode:
- Several US pharma giants stage Q2 sales turnaround after subpar results earlier in year
- The battle of the obesity drug heavyweights
- 7 top pharmas posted revenue declines in Q1. The common thread? All are US firms
- Biopharma briefing: Q1 trends, gene therapy updates and ASCO preview
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While it’s been easy to grow a bit desensitized to the seemingly unstoppable sales growth of Novo Nordisk and Eli Lilly’s GLP-1s quarter after quarter, this most recent earnings season delivered a few surprises. It’s a good moment to jump back in and assess where the two rivals stand in the market and where their pipelines are headed in the near term.
In this week’s episode of "The Top Line," we break down the recent commercial performances of Novo’s and Lilly’s drugs for diabetes and obesity, plus the status of their oral obesity med prospects. Fierce Biotech’s James Waldron sits down with Fierce Pharma’s Fraiser Kansteiner to discuss the latest in the companies’ ongoing obesity duel, as well as some recent pitfalls that seem common to GLP-1 development and commercialization more broadly.
To learn more about the topics in this episode:
- Novo's outgoing CEO prepares to hand off business as sales threats from Lilly, GLP-1 compounders persist
- Amid MFN talks, Lilly chief warns US adoption of international drug prices could bring 'worst of two worlds'
- Novo Nordisk drops 2 obesity drugs as part of major pipeline clearout
- Lilly's oral GLP-1 data 'as good as it gets' at 12% weight loss, exec says
- Pfizer's embattled obesity program loses another GLP-1 over poor data and strong competition
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Following a barrage of letters from President Donald Trump urging 17 large pharmaceutical companies to implement Most Favored Nation drug pricing reforms in the U.S., analysts and industry watchers are questioning how far the president’s authority extends, while several drugmakers have signaled a willingness to negotiate.
In this week’s episode of "The Top Line," we break down the latest Most Favored Nation pricing pressures in the U.S., how companies are responding and which facets of the proposal might fall short of Trump’s goals. Fierce Pharma’s Eric Sagonowsky and Fraiser Kansteiner discuss the current state of those reform efforts and past attempts to rein in U.S. drug costs, followed by a brief discussion on tariffs.
To learn more about the topics in this episode:
- Pfizer CEO touts 'extremely productive' talks with Trump administration as MFN pricing, tariff threats close in
- White House threatens to 'deploy every tool in our arsenal' to implement most-favored-nation drug pricing
- All branded drugs not facing generic, biosimilar competition must abide by MFN order in 'all markets,' HHS tells pharma
- Trump ups the ante on pharma tariffs, saying they will reach 250%
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In the latest episode of Health Matters, vaccine expert Dr. Paul Offit joins host Wendy Lund to discuss the growing crisis of vaccine hesitancy and what can be done to rebuild trust. Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, points to the COVID-19 pandemic as a turning point, citing perceived government overreach and widespread misinformation as key drivers of public distrust. He emphasizes that vaccine hesitancy is often rooted in reasonable concerns and calls on health care professionals to respond with empathy, not judgment.
Offit also outlines steps the industry can take to regain credibility, including amplifying trusted community voices, improving science communication, and putting a human face on pharmaceutical innovation. He shares moving stories from the field, including one about Dr. Penny Heaton’s work to develop a rotavirus vaccine and bring it to children in need. “We all want the same thing,” Offit says. “Healthy children, protected from preventable diseases.” Listen to the full episode for more insights on how the health care sector can meet this moment with clarity and compassion.
Disclaimer:
All information provided on this podcast is for informational purposes only and does not constitute medical advice. You should consult with qualified healthcare professionals before making any decisions related to your health. Any opinions expressed are those of the individuals expressing them and do not represent the views of the podcast or its affiliates.
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Over a whirlwind three weeks, Sarepta Therapeutics has faced tough safety questions around its commercial gene therapy Elevidys and growing scrutiny over the company’s transparency following multiple patient deaths.
In this week’s episode of "The Top Line," we explore Sarepta’s brief standoff with the FDA over Elevidys, a short-lived marketing pause, and the regulator’s surprise reversal on the treatment. Fierce Pharma’s Fraiser Kansteiner and Angus Liu sit down with Fierce Biotech’s Gabrielle Masson to recap the story and discuss the broader implications the Elevidys saga may have for gene therapy, the FDA and the pharmaceutical industry.
To learn more about the topics in this episode:
- Sarepta pivots to siRNA and lays off 500 staffers as Elevidys gets box warning
- Sarepta LGMD trials all hit by FDA hold amid newly surfaced safety concerns over gene therapy
- Sarepta, bowing to FDA pressure, pauses shipments of Duchenne gene therapy Elevidys
- FDA takes U-turn on Sarepta's Elevidys, backing Duchenne gene therapy again in ambulatory patients
- Analysts demand transparency after Sarepta's roundabout disclosure of 3rd patient death
- Roche won't throw in the towel after DMD gene therapy Elevidys' rebuff in Europe
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With an uptick in licensing deals and promising data emerging from China-based biopharmas, especially in oncology, it’s clear the country is poised to play a major role in life sciences for the foreseeable future.
In this week’s episode of "The Top Line," we trace China’s ascent in R&D and drug discovery and examine how U.S. and European drugmakers are capitalizing on the momentum through a surge in licensing activity.
Fierce Pharma’s Fraiser Kansteiner sits down with Mark Lansdell, director at Evaluate, to break down the policies fueling China’s growth, how global companies are engaging with Chinese assets and which modalities and indications are commanding the most attention.
To learn more about the topics in this episode:
- China approves 4 new drugs, including a global first-in-class medicine
- With China approval, Lilly and Innovent's mazdutide breaks into new class for GLP-1 obesity drugs
- China biotechs ‘reshaping’ US biopharma as outlicensing deals rise 11%: Jefferies report
- China proposes shorter clinical trial reviews in efforts to accelerate drug development
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In this episode of "The Top Line," Ayla Ellison, Editor-in-Chief of Fierce Life Sciences and Healthcare, sits down with two longtime industry leaders to talk about what it takes to stand out and grow in today’s pharma marketing landscape.
Zoe Dunn, president and CEO of Hale Advisors, and Paul Murasko, head of digital innovation and marketing operations at Azurity Pharmaceuticals, reflect on how the industry has evolved—from print to digital to AI—and what early-career professionals need to know to thrive. As co-chairs of the Rising Stars program at this year’s Fierce Pharma Week, Dunn and Murasko share their insights on mentorship, innovation and how the next generation can navigate a highly regulated field while staying grounded in the fundamentals.
To learn more about the topics in this episode:
- Fierce Pharma Week Information and Agenda
- Fierce Pharma Week Registration
- Rising Stars Program at Fierce Pharma Week
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Layoffs in biopharma show no signs of slowing, with workforce reductions holding steady across the first two quarters of 2025.
In this week’s episode of "The Top Line," Fierce Deputy Editor Andrea Park and Fierce Biotech Senior Editor Gabrielle Masson break down the latest layoff trends and how they compare to last year.
Tune in for a look at the numbers so far, the pace of biotech closures and how federal policy shifts are affecting the industry.
To learn more about the topics in this episode:
- Biopharma layoffs for first half of the year jump 32% YOY
- Fierce Biotech Layoff Tracker 2025
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In the latest episode of the Health Matters podcast, Wendy Lund sits down with Peter Pitts, former FDA associate commissioner and current president of the Center for Medicine in the Public Interest, to discuss the state of regulatory science and communication in health care. Pitts shares a cautiously optimistic outlook for the FDA under Commissioner Makary, noting the agency's renewed focus on innovation, patient engagement and modernization. He also stresses the importance of alignment among marketing, legal and regulatory teams—what he calls “regulatory therapy”—to ensure health communications serve the public good.
The conversation spans high-stakes topics such as direct-to-consumer advertising, misinformation, and missed PDUFA dates, with Pitts urging both regulators and industry leaders to improve transparency and collaboration. He calls on pharmaceutical companies to put patients first in communications and avoid blaming the FDA when approvals stall. Pitts also encourages the agency to learn from industry on how to better engage the public. For more insights—and a candid look at where the health care conversation needs to go—tune in to the full episode.
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Two and a half years into his tenure as Teva’s CEO, Richard Francis is breaking down the strategy that’s powered the company through nine consecutive quarters of growth.
On this week’s episode of "The Top Line," Fierce Pharma’s Fraiser Kansteiner sits down with Francis to talk about the progress made so far on Teva’s “Pivot to Growth” strategy and what comes next. They dig into the strategies behind the company’s chief commercial medicines, its pipeline darlings and the way Teva’s generic and biosimilar backbone is expected to evolve through the end of the decade.
To learn more about the topics in this episode:
- As Austedo, Ajovy and Uzedy gain steam, Teva banks on $5B-plus in 2030 innovative drug sales
- Teva plots thousands of job cuts as restructuring drive enters 'acceleration' phase
- Teva taps Matthew Shields to oversee manufacturing and supply division amid company revamp
This week's episode is sponsored by Cencora.
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Antibody drug conjugates, or ADCs, are still holding on to their spot as one of the hottest areas in cancer care—and AbbVie, like many of its peers, has embraced the trend head-on.
In this week’s episode of "The Top Line," Fierce Pharma’s Zoey Becker speaks with Daejin Abidoye, M.D., AbbVie’s vice president and therapeutic area head for solid tumor oncology. They discuss the company’s evolution, trends from this year’s American Society of Clinical Oncology meeting and what’s ahead for ADCs in oncology.
AbbVie, a newer player in the ADC space, recently earned FDA approval for Emrelis in adults with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who have previously received systemic therapy. With a robust pipeline of ADCs in development, Abidoye envisions a bright future for the class—one that could herald “a new era” of cancer treatment beyond traditional chemotherapy.
To learn more about the topics in this episode:
- AbbVie advances solid tumor agenda with FDA nod for lung cancer ADC Emrelis
- AbbVie pays $10B to acquire ImmunoGen, doubling down on red-hot ADC cancer field
- Replacing chemotherapy with ADCs? AbbVie rebuilds next-gen assets after Rova-T flop
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Every year, the Fierce Medtech team highlights 15 standout companies that are pushing the boundaries of innovation in medical technology. From reinventing diagnostics and surgical tools to advancing AI and biological research, this year’s Fierce 15 is full of startups rethinking what care should look like—and improving on what came before.
In this episode of "The Top Line," Fierce Medtech Senior Editor Conor Hale breaks down the themes and standout trends from this year’s list, offering a closer look at the ideas and technologies reshaping the healthcare landscape.
To learn more about the topics in this episode:
- Introducing Fierce Medtech's Fierce 15
This episode is sponsored by Cencora.
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Each year, the American Society of Clinical Oncology annual meeting brings together the biggest names and brightest minds in cancer research, and this year was no exception.
In this episode of "The Top Line," Fierce reporters take you inside the action at ASCO 2025. Zoey Becker shares the story behind Johnson & Johnson’s dramatic “Breathtaking” campaign, staged on the 99th floor of Chicago’s Willis Tower. Angus Liu breaks down phase 3 data on Enhertu from AstraZeneca and Daiichi Sankyo, while Gabrielle Masson overviews Bicara Therapeutics' investigational asset for head and neck squamous cell carcinoma.
Plus, the team compares notes from the ASCO exhibit hall.
To learn more about the topics in this episode:
- ASCO: AstraZeneca, Daiichi flex Enhertu's muscles in first-line breast cancer as they drop new phase 3 gastric cancer data
- 'Our data is resonating far more with the people that matter,' Bicara CEO says amid Merus race
- ASCO: J&J highlights Rybrevant-Lazcluze combo in 'Breathtaking Moments' lung cancer campaign high over Chicago skyline
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In this episode of The Top Line, Fierce Biotech’s Chris Hayden sat down with Dr. Juergen Eckhardt of Bayer and Dr. Seth Ettenberg of BlueRock Therapeutics to discuss an innovative partnership that’s reshaping how big pharma teams up with biotech startups.
BlueRock, a wholly owned subsidiary of Bayer, operates with the independence of a small biotech while benefiting from Bayer’s global reach and infrastructure. The “arm’s-length” model gives BlueRock the agility to innovate while leveraging Bayer’s resources in manufacturing, clinical trials and commercialization.
The collaboration has already led to major milestones, including the development of a promising cell therapy for Parkinson’s disease, which is expected to enter Phase 3 trials later this year.
“This isn’t just a partnership—it’s a relationship,” Eckhardt said. “We’re combining the best of both worlds: biotech speed and pharma scale.”
The episode also explores how Bayer’s experience in biologics manufacturing has helped BlueRock overcome one of regenerative medicine’s biggest challenges—scaling complex cell therapies. The model has proven so effective that Bayer has since replicated it with other companies, signaling a broader shift in how the company approaches innovation.
To learn more about this unique partnership and what it means for the future of neurological disease treatment, listen to the full episode of The Top Line.
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In the latest episode of The Top Line podcast, host Heath Clendenning interviews Cheryl Lubbert, CEO of Reverba Global, to discuss how science-led storytelling is reshaping communications in the pharmaceutical industry. Lubbert, a veteran executive with experience at Amgen, Abbott and Bristol Myers Squibb, says authenticity, empathy and transparency are now critical to rebuilding public trust. She argues that scientific data, when paired with real patient and caregiver stories, becomes more impactful—helping both healthcare providers and patients better understand and engage with treatments.
Lubbert also highlights the growing importance of breaking down silos between marketing and medical affairs. By integrating these functions, she says pharma companies can provide more consistent, credible messaging and support shared decision-making in clinical settings. With real-world examples—from peer mentorship programs to immersive educational initiatives—Lubbert makes a compelling case for treating storytelling as a strategic tool, not just a creative one. For more on how these approaches are driving better outcomes, listen to the full episode of The Top Line.
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Despite the long holiday weekend, news in biopharma never slows down.
In this week’s episode of "The Top Line," the Fierce team breaks down some of the biggest stories from the past week.
On the pharma side, Eric Sagonowsky and Kevin Dunleavy examine Big Pharma’s first-quarter 2025 performance. While most of the top 25 companies are still delivering strong sales growth despite emerging uncertainties in Washington, D.C., a few major players are starting to see a slowdown. Each company tells a different story, and Sagonowsky and Dunleavy dive into the nuances of the current commercial landscape.
Later, Fierce Biotech's Gabrielle Masson and Darren Incorvaia highlight key data from the American Society of Gene & Cell Therapy conference and preview what the team is watching at this week’s American Society of Clinical Oncology annual meeting.
To learn more about the topics in this episode:
- Seven top pharmas posted revenue declines in Q1. The common thread? All are US firms
- Atsena eye disease gene therapy hits safety goals, closes retinal splits in phase 1/2
- ASGCT: Analysts see Rocket gene therapy setting 'a new bar' for efficacy in heart condition
- Rocket crashes as gene therapy patient dies, FDA imposes hold
This episode is sponsored by Cencora.
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President Donald Trump put the pharmaceutical industry on notice early Monday with the signing of his "most favored nation" (MFN) executive order on drug prices. The order seeks to tie U.S. prices to significantly lower costs overseas.
Many questions remain about how the measure will be implemented, and legal challenges are almost certain. To assess the seriousness of the threat, Fierce Pharma assembled a team of reporters and editors to break down the executive order and the industry’s response.
After examining the MFN executive order, the group dives into other recent policy developments in Washington, D.C., and beyond, including tariffs, Medicare drug price negotiations and more.
To learn more about the topics in this episode:
- Trump signs sweeping executive order to cut US drug prices by 'up to 90%'
- Sanofi, Novartis CEOs lambast EU price control as Trump reportedly weighs drug cost parity with other nations
- As Trump threatens tariffs on drugs, industry warns EU of $100B-plus pharma exodus to US
- US net drug spending surged 11.4% last year, boosted by obesity and oncology meds: IQVIA
This episode is sponsored by Cencora.
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Angela Hwang spent nearly three decades at Pfizer before joining Flagship Pioneering in 2025 as a CEO-partner and the CEO of Metaphore Biotechnologies.
In this week’s episode of "The Top Line," the former Pfizer chief commercial officer speaks with Fierce Pharma Deputy Editor Angus Liu about her transition from marketing drugs at a Big Pharma company to advancing novel technology at a young biotech startup.
Hwang discusses how her upbringing in apartheid-era South Africa—and two key lessons from her career—shaped who she is today. A longtime champion of diverse talent, she emphasizes that regardless of the broader environment or the size of an organization, it’s essential to ensure “everybody has a chance of developing in their careers and that they have a level playing field.”
To learn more about the topics in this episode:
- 'We have not seen anything similar': Novo Nordisk pens $600M obesity pact with Flagship's Metaphore
- 2022's Fiercest Women in Life Sciences—Angela Hwang
- Done deal: Pfizer completes $43B acquisition of Seagen, doubling its oncology pipeline
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Although East Asians make up a significant share of entry-level roles in U.S. biopharma, few have risen to senior leadership positions. That disparity is what inspired the launch of ElevAAte—a new nonprofit founded this year to support and grow East Asian American leadership in the industry.
In this week’s episode of "The Top Line," Fierce Pharma Deputy Editor Angus Liu speaks with two of ElevAAte’s co-founders: Architect Therapeutics CEO Angie You and Candid Therapeutics CEO Ken Song. The veteran biotech leaders discuss why a group like ElevAAte is needed and how East Asian Americans can harness their collective strength to build the next generation of biopharma executives.
You and Song—who led Amunix’s $1.2 billion sale to Sanofi and RayzeBio’s $4.1 billion acquisition by Bristol Myers Squibb, respectively—also share insights from their dealmaking careers and offer advice for young professionals entering the field.
To learn more about the topics in this episode:
- Though prevalent in the lab and middle management, East Asian Americans are underrepresented in biopharma C-suites: report
- Candid's T-cell engager shopping spree rolls on with WuXi Biologics pact worth up to $925M
- A reason to fight: Former FDA leader Janet Woodcock inspires 3rd Biotech Sisterhood summit
- Takeda taps Julie Kim to take over for retiring CEO Christophe Weber
This episode is sponsored by Cencora.
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We’ve known for a while that there are two Anguses—both journalists covering oncology at health- and biopharma-focused news outlets. Now, for the first time, we’re bringing them together for a “Variety Studio: Actors on Actors”-style conversation.
In this week’s episode of "The Top Line," Fierce Pharma Deputy Editor Angus Liu and STAT Cancer Reporter Angus Chen share insights into their work covering cancer and their thoughts on racial identity during a tumultuous time.
They discuss what excites them most in the oncology field, how their reporting approaches differ and how they’ve often been mistaken for one another.
To learn more about the topics in this episode:
- Judge permanently blocks NIH grant caps, prompting HHS appeal
- Cancer research, long protected, feels ‘devastating’ effects under Trump
- As Trump targets DEI practices, 4 pharmas reaffirm commitment to diversifying clinical trials
- For struggling cell and gene therapy field, Peter Marks' FDA exit adds even more uncertainty
- CAR-T cells can arm other immune cells with engineered proteins to fight cancer, study says
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After a batch of much-anticipated reciprocal tariffs spared pharmaceuticals in early April, drugmakers, medtech companies, manufacturers and other outfits across the life sciences spectrum are still scrambling to respond to mounting trade pressures. While many unknowns remain, biopharma companies should waste no time in starting to evaluate their options.
In this week’s episode of “The Top Line,” we dig into the latest round of tariffs unveiled by the Trump administration and how they could impact multiple areas of the life sciences industry. Fierce Pharma’s Fraiser Kansteiner sits down with KPMG’s life sciences sector leader Kristin Pothier, who discusses how the current tariffs could pose challenges, how drugmakers and other life sciences companies should respond and whether additional sector-specific duties are on the horizon.
To learn more about the topics in this episode:
- As Trump's 'Liberation Day' tariffs seem to spare pharmaceuticals, threat of industry-specific duties and loopholes persists
- Drugmakers fear Trump tariffs will drive up manufacturing costs, hurt medicine access: BIO survey
- Eli Lilly CEO on Trump's tariffs: 'It'll be hard to come back from here'
- Trump again threatens tariffs on pharmaceuticals in 'not too distant' future
This episode is sponsored by Cencora.
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Since the introduction of the BIOSECURE Act in January, named companies and U.S.-based biopharmas alike have speculated on what the legislation could mean for the life sciences industry.
In this week's episode of "The Top Line," Fierce Pharma staff writer Fraiser Kansteiner sits down with Arnold & Porter’s Life Sciences practice chair Dan Kracov to discuss the broader implications of the bill, and what the likely next steps are for the legislation to become law.
Kracov also breaks down what measures life sciences companies are already taking in light of the bill and concessions that may need to be made to appease lawmakers on both sides of the aisle.
To learn more about the topics in this episode:
- After BIOSECURE Act passes in House, targeted Chinese companies say they're 'deeply' concerned
- Despite looming BIOSECURE threat, pharma contracting giant WuXi Bio scoops up new projects
- Lawmakers urge FDA to investigate clinical trials run in tandem with China's military
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At the recent World Conference on Lung Cancer and European Society for Medical Oncology annual meetings, two packages of lung cancer data from a partnership between Akeso and Summit Therapeutics and another collaboration between iTeos Therapeutics and GSK showed much promise of disrupting the current standard of care. But they also drew some questions and debate.
In this week's episode of “The Top Line,” Angus Liu from Fierce Pharma and Gabrielle Masson from Fierce Biotech discuss the key issues behind those two readouts.
To learn more about the topic in this episode:
- iTeos-GSK's TIGIT combo shows 30% more tumor shrinkage than Jemperli, but safety signals scare investors
- Akeso, Summit's PD-1 bispecific crushes Merck's Keytruda in study, signaling potential new standard in lung cancer
- 'Cooking with gas': Regeneron sees its Opdualag rival as next big thing for treating solid tumors
- ESMO: Bristol Myers moves Opdualag into phase 3 trials in competitive first-line lung cancer field
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In this week's episode of "The Top Line," we’re recapping and discussing the major trends from Digitial Pharma East, which took place in Philadelphia last week. The event brought together marketing experts from across the life sciences industry.
Fierce Pharma Marketing's Andrea Park and Ben Adams talk about major trends from the event that came up in conversations, including the complicated current attitudes toward artificial intelligence in this space.
They also highlight some winners of the annual Fierce Pharma Marketing Awards, held on the final night of Digital Pharma East.
To learn more about the topics in this episode:
- Navigating the AI 'hype cycle': Bayer, Daiichi Sankyo and argenx leaders on implementing AI in biopharma marketing
- Pfizer, Sanofi, GSK among the winners of the 2024 Fierce Pharma Marketing Awards
- Two-thirds of top 20 pharmas have banned ChatGPT—and many in life sci call AI 'overrated,' survey finds
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In this week's episode of "The Top Line," we will dive into the annual Fierce 50 special report.
We share the stories of a select few 2024 Fierce 50 honorees and interesting highlights from this year's special report.
To learn more about the topics in this episode:
- Fierce 50 of 2024
- Innovation Honorees
- Health Equity Honorees
- Social Impact Honorees
- Breakthroughs Honorees
- Patient Advocacy Honorees
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In this week's episode of "The Top Line," we’re looking at what goes into manufacturing and supply of flu vaccines.
Fierce Pharma’s Zoey Becker chats with Stefan Merlo, vice president of commercial operations, North America at CSL Seqirus. He discusses the company's differentiated flu vaccine portfolio and how its manufacturing process has evolved over the decades to create and distribute vaccines offering targeted protection each year.
To learn more about the topics in this episode:
- Driving flu vaccine uptake in the post-pandemic era
- Flu vaccine makers CSL Seqirus, Sanofi and GSK kick off initial shipments ahead of upcoming season
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In this week's episode of "The Top Line," we look at factors driving the continuing decline of flu vaccination rates in the U.S. and beyond.
Fierce Pharma’s Zoey Becker chats with Gregg Sylvester, M.D., Chief Health Officer at CSL Seqirus, to get insight on what we might expect to see from this upcoming flu season. He also explains efforts to increase vaccine uptake through awareness and education campaigns.
To learn more about the topics in this episode:
- Flu vaccine makers CSL Seqirus, Sanofi and GSK kick off initial shipments ahead of upcoming season
- CDC starts 'Wild to Mild' campaign to reverse falling flu vaccine use in key groups
- American Lung Association, Sanofi urge high-risk communities to grab their flu shots in 'United Against Flu' campaign
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Biotherapeutics are transforming healthcare for over 350 million patients globally, tackling everything from cancer and diabetes to rare diseases.
Human embryonic kidney (HEK) 293 cells play a key role in the manufacturing of many of these life-changing products. However, they are not without their challenges.
In this episode of The Top Line, sponsored by Bio-Rad, Dipika Gurnani, Global Product Manager at Digital Biology Group, discusses the critical need to accurately quantify HEK293 DNA in biotherapeutics to ensure patient safety and regulatory compliance.
Gurnani highlights the risks of residual DNA integrating into a patient's genome, potentially causing cancer or genetic abnormalities. She also addresses the limitations of traditional quantification methods like qPCR, which can be time-consuming and prone to errors.
We also look at some key innovations in the field, such as Bio-Rad’s Vericheck ddPCR HEK293 Residual DNA Quantification Kit that can minimize false positives by specifically targeting HEK293 DNA.
For deeper insights into these challenges and innovations, listen to the full episode.
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For the last 40 years, when federal legislation was ambiguous or left an administrative gap, courts were required to defer to the interpretation of agencies. This stipulation, called the Chevron deference, gave agencies room to advance their regulatory priorities.
The Supreme Court overturned the doctrine in June, bringing significant implications for the healthcare industry and federal regulators like the FDA.
In this week's episode of "The Top Line," Fierce Pharma’s Kevin Dunleavy chats with Project Farma President Anshul Mangal about the potential impact on the biopharma industry.
To learn more about the topics in this episode:
- Supreme Court overrules Chevron deference, dealing blow to federal healthcare agencies
- The Supreme Court just limited federal power. Healthcare is feeling the shock waves
- How Chevron's demise could impact employers, purchasers and health payers
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The TROP2 antibody-drug conjugate race has heated up among three Big Pharma companies: Gilead Sciences, AstraZeneca and Merck.
Fierce Pharma’s Angus Liu recently took a deep dive into the three TROP2 front-runners. In a feature article, he examined the strengths and potential challenges facing each candidate, as well as the considerations behind their extensive phase 3 programs and their various development strategies.
In this week’s episode of “The Top Line,” Fierce executive editor Eric Sagonowsky chats with Liu about his feature story on the three TROP2 front-runners.
To learn more about the topics in this episode:
- 3 Big Pharma companies, 33 phase 3 trials: The race for supremacy in an ADC field
- ASCO: Gilead looks for silver lining in Trodelvy’s failed lung cancer trial. But will the FDA play ball?
- AstraZeneca-Daiichi's Enhertu follow-up Dato-DXd unable to prove overall survival benefit in phase 3
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In this week's episode of "The Top Line," we’re diving into Fierce Biotech’s annual Fierce 15 special report.
Fierce Biotech's Annalee Armstrong and Gabrielle Masson take you behind the scenes to explore the meticulous selection process and share interesting highlights from this year’s honorees.
To learn more about the topics in this episode:
- Introducing Fierce Biotech's 2024 Fierce 15
- Fierce Biotech's Gabrielle Masson presents Fierce 15 at NYSE
- Fierce 15: Where are they now?
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This week on “The Top Line,” we discuss two studies in HIV research that were presented at the 25th International AIDS Conference in Germany.
One of them is the report of a 7th person who has likely been cured of HIV. And there’s something unique about this case that has sparked excitement among scientists.
The other one is the report of a long-acting injection that showed 100% efficacy in preventing HIV infection in a phase 3 trial. Some experts have hailed the PrEP candidate as a game-changer.
To dive deeper into these studies, Fierce Pharma’s Angus Liu interviews Jared Baeten, M.D., Ph.D., senior vice president and head of clinical development of the virology therapeutic area at Gilead Sciences.
To learn more about the topics in this episode:
- With seventh person seemingly cured of HIV, signs of hope for a broader cure
- Watch out, GSK. Gilead’s twice-yearly PrEP drug shows 100% efficacy for HIV prevention
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In this week’s episode of "The Top Line," Fierce Biotech’s Annalee Armstrong highlights some of the most promising companies that made our prestigious Fierce 15 list back in 2014.
A decade later, she revisits these trailblazers to see how they’ve navigated the biotech landscape.
To learn more about the topics in this episode:
- Fierce Biotech's Fierce 15 of 2014
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Back in February, Novo Holdings laid out a $16.5 billion deal to snap up contract manufacturing giant Catalent. In this week's episode of "The Top Line," we dive into the current state and implications of the proposed buyout.
Fierce Pharma’s Fraiser Kansteiner is joined by former FTC policy director David Balto. They discuss the likelihood of the deal going through, potential regulatory hurdles and what the transaction could mean for the greater CDMO landscape.
To learn more about the topics in this episode:
- Another day, another delay for Novo's Catalent acquisition as FTC imposes 'Second Request'
- Novo antes up $16.5B to poach CDMO giant Catalent amid Wegovy surge
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In this episode of The Top Line, sponsored by the Parenteral Drug Association (PDA), we explore the upcoming PDA/FDA Joint Regulatory Conference, happening September 9-11 in Washington, D.C.
Our guest, Janeen Skutnik-Wilkinson, Director of Global Quality Regulatory Surveillance and External Engagement for Moderna and Co-Chair of the 33rd annual event, shares why this conference is the essential annual CGMP event to attend.
Janeen notes the direct access to federal regulators and the unique insights from FDA colleagues as standout features. The FDA co-sponsored conference is known for fostering collaboration among scientific minds to create practical solutions and best practices, with this year's focus on improving quality culture, shifting to proactive approaches, and evolving quality maturity.
Key sessions will cover de-risking quality control environments by utilizing case studies on OOS and OOT results, and enhancing lab systems with QRM. The conference's focus on Current Good Manufacturing Practices (CGMP) makes it a must attend for quality assurance and operations professionals. Additionally, discussions will delve into the role of AI in manufacturing and data integrity.
For a comprehensive look at this year's PDA/FDA Joint Regulatory Conference, listen to the full episode and register at pda.org/PDAFDA2024.
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Pharmaceutical CEOs often earn pay packages worth tens of millions of dollars for leading the top drugmaking companies in the industry. Every year, some new faces enter the rankings while others leave.
In this week's episode of "The Top Line," Fierce Pharma’s Eric Sagonowsky and Fraiser Kansteiner discuss Fierce’s annual special report, “Big Pharma's 10 highest-paid CEOs.”
Aside from digging into the specific numbers surrounding CEO pay packages, the discussion also touches on CEO-to-worker pay ratios for 2023 and more.
To learn more about the topics in this episode:
- Big Pharma's 10 highest-paid CEOs of 2023
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At Fierce Biotech, we love a big M&A deal, but valuation does not always equal the most exciting.
In this week's episode of "The Top Line," Fierce Biotech’s Annalee Armstrong and James Waldron discuss what they think are the best and smartest acquisitions in recent years.
From obesity to radiopharmaceuticals, they give you the Fierce Biotech team’s thoughts on who got the best deal.
To learn more about the topics in this episode:
- Top 10 smartest deals in biopharma
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In this week’s episode of “The Top Line,” Fierce Pharma’s Zoey Becker sits down with Bobby Sheng, the CEO of Bora Pharmaceuticals, to discuss the concept of “friend-shoring” in drug manufacturing.
"Friend-shoring" involves conducting manufacturing processes in countries considered friendly or allied. Sheng discusses the criteria for deeming a country “friendly” and explores whether this strategy could help address drug supply shortages.
To learn more about the topics in this episode:
- Bora plants its flag in the US with $210M acquisition of generics manufacturer Upsher-Smith
- Emergent, pivoting away from CDMO business, sells Baltimore plant to acquisitive Bora for $30M
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Each June, the American Society of Clinical Oncology (ASCO) hosts a conference that gathers physicians, researchers and the cancer community to share their latest research on treatments, technologies and more.
The Fierce team is always on the ground at the ASCO meeting, and this year, Fierce Biotech’s Gabrielle Masson and Fierce Pharma’s Angus Liu covered the event.
In this week's episode of "The Top Line," they discuss the most talked-about data drops at ASCO and share on-the-ground details, including their experience with Gilead’s virtual reality Trodelvy ride.
To learn more about the topics in this episode:
- Akeso, Summit's Keytruda win draws 'explosive' interest at ASCO. But what does Merck think?
- ASCO: After Keytruda, Merck builds 3-pronged cancer strategy starring Moderna-partnered vaccine
- ASCO: Cautious Big Pharmas double down on past wins—steering clear of radioligands and cell therapy
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The Fierce Pharma Marketing team publishes a special report each year on the top pharmaceutical drug ad spenders. This year’s report, which includes numbers for 2023, was published on Monday.
AbbVie was the standout in this edition, having spent heavily on ads for Skyrizi and Rinvoq. Overall spending on the top 10 ads also experienced a sizable increase compared to the previous year.
In this week’s episode of “The Top Line,” Fierce Pharma Marketing Senior Editor Ben Adams and Deputy Editor Andrea Park discuss the report, providing key insights and takeaways.
To learn more about the topics in this episode:
The top 10 pharma drug ad spenders for 2023
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The Fierce Biotech team published a four-part series this week exploring cell therapy, a modality that has faced clinical challenges, manufacturing constraints and multiple practice-changing events.
In today’s episode, Fierce’s Annalee Armstrong and Gabrielle Masson discuss the series of special reports and key insights from their interviews with multiple experts.
To learn more about the topics in this episode:
- Cell therapy reckoning: How a 'remarkable resolution of lupus' carried CAR-T from cancer to immunology
- Cell therapy reckoning: Pivot to autoimmune leaves unmet need in oncology
- Biotech faces a reckoning: 'We've lost our luster in cell therapies'
- Fulfilling the promise of cell & gene therapies through manufacturing (Part I)
- From cell collection to commercial contracting: Advancements in cell & gene therapy manufacturing (Part II)
- Automation, decentralization and the future of CAR-Ts: Advancements in cell & gene therapy manufacturing (Part III)
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This week’s episode of “The Top Line,” is the final part of a three-part series diving into the latest advancements in cell and gene therapy manufacturing.
In this episode, Fierce Pharma’s Fraiser Kansteiner is joined by Bruce Levine, Ph.D., who is the co-inventor of Kymriah and the Barbara and Edward Netter Professor in Cancer Gene Therapy at the University of Pennsylvania. He’s also joined by executives from CGT technology provider ScaleReady and regenerative cell therapy developer CellProthera.
They dive into novel production approaches discussed earlier in this series, with a special focus on CAR-T therapies.
To learn more about the topics in this episode:
- CAR-T hype faces infrastructure reality check
- CAR-T boxed warnings: What comes next?
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In the fast-paced field of life sciences, digital pathology is poised to be a game-changer.
In this episode, we sit down with Grace Lee and Douglas Clark of Agilent Technologies to explore the opportunities and challenges associated with companion diagnostics (CDx).
Clark kicks off, shedding light on the current levels of digital pathology adoption in both clinical trials and practice. Thereafter, Lee outlines several opportunities and the associated regulatory hurdles, looking at areas such as the utilization of whole slide images for companion diagnostic interpretation.
Pointing to the amplified scrutiny on Laboratory Developed Tests (LDTs) and the emerging CDx guidelines in the EU and China, she emphasizes the importance of aligning with agencies: “Oftentimes we are trying to manage changes in the CDx world by providing regulators with evidence that assay performance has not changed.”
Clark echoes these sentiments, first highlighting the challenges posed by image variability and the resultant disparities in CDx interpretation and scoring, and then offering an optimistic outlook on the transformative potential of AI in the realm of multiplexing assays.
For a deep dive into the opportunities presented by digital pathology and CDx development, tune into the full episode.
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What is the transformative potential of digital health technologies in advancing health equity? Rabin Martin, a global health consulting firm, explores those possibilities in this engaging episode.
The conversation highlights the excitement surrounding digital tools and advanced analytics in achieving deeper insights, consistent care delivery, workforce support, and addressing social determinants of health.
Listen in now.
Host: Heath Clendenning, Fierce Life Sciences
Producers: Matt Rickman and Samantha Mazzotta
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This week’s episode of “The Top Line” is the second part of a three-part series exploring the latest advancements in cell and gene therapy manufacturing.
In this episode, Fierce Pharma’s Fraiser Kansteiner interviews Delara Motlagh, head of cell therapy at Catalent; Becky Butler Cap, senior vice president of biotherapies at Vitalant; and Kevin Kyle, CEO of Germfree.
The conversation covers cell collection, the critical first step in advanced therapy manufacturing. They also discuss the importance of locking in process decisions early and how to effectively scale projects from the lab to the clinic and eventually to the market. Additionally, they talk about Germfree’s recent asset acquisition from Orgenesis, which will allow the company to expand its mission of decentralized manufacturing.
To learn more about the topics in this episode:
- Fulfilling the promise of cell & gene therapies through manufacturing (Part I)
- With new partnership, Galapagos takes decentralized CAR-T manufacturing quest nationwide
- Catalent opens cell therapy production site at Belgian 'center of excellence'
- After recent troubles, Catalent expands its biologics services platform
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This week’s episode of “The Top Line,” kicks off a series diving into the latest advancements in cell and gene therapy manufacturing.
In this episode, Fierce Pharma’s Fraiser Kansteiner sits down with Ori Biotech CEO Jason Foster and the Cell Therapy Manufacturing Center's CEO, Jason Bock. They delve into the current state of cell and gene therapy manufacturing and consider if the existing production methods can keep up with the potential of personalized medicines.
They also dive into past hurdles in the space and highlight the varied approaches—including their own—that a new generation of cell and gene therapy manufacturing companies have been pioneering.
To learn more about the topics in this episode:
- Ori Biotech taps MD Anderson, National Resilience joint venture to put its automated cell and gene therapy manufacturing tech to the test
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This week on "The Top Line," we're diving into the details of the spree of big-money biopharma deals in 2023 and examining what that means for this year.
Fierce Pharma Senior Writer Kevin Dunleavy sits down with Cody Powers, a consultant who advises companies on business development and franchise growth strategy, to discuss the reasons behind the numerous high-value deals in 2023, which companies are primed to make major moves this year, and whether the trend of acquiring ADCs and obesity treatments will continue.
To learn more about the topics in this episode:
- The top 10 biopharma M&A deals of 2023
- 2024 forecast: M&A saw an uptick in 2023. Analysts expect the trend to continue
- For biopharma M&A, the best returns come from small deals: analysts
See omnystudio.com/listener for privacy information.
Fierce Pharma publishes a yearly special report highlighting the top 20 pharmas based on their revenue. The most recent edition, published this month, ranks each pharma based on their total revenues for 2023.
This week on "The Top Line," Fierce Pharma Senior Editor Eric Sagonowsky and Senior Writer Kevin Dunleavy break down the numbers, highlight key trends and share some of the biggest changes at the top and bottom of the rankings year over year.
To learn more about the topics in this episode:
- The top 20 pharma companies by 2023 revenue
- The top 20 pharma companies by 2022 revenue
See omnystudio.com/listener for privacy information.
This week on “The Top Line,” we're joined by Fierce Biotech Senior Editor Annalee Armstrong and Fierce Pharma Marketing Senior Editor Ben Adams. We're diving into our recent spin on March Madness at Fierce.
This time around, Fierce Biotech kicked off its inaugural Best Biotech Name tournament, while over at Fierce Pharma Marketing, we held our biannual Drug Names tournament.
The editors discuss what makes a company or drug name tick, what to steer clear of, and how the entire competition played out.
To learn more about the topics in this episode:
-
FierceMadness: AstraZeneca and Ionis cruise to victory as Wainua trounces Lilly's Mounjaro for the tournament win
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FierceMadness: The Best Biotech Name Tournament—A champion is CROWNED
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Jeff Beck of BioCare is in the hotseat for this edition of The Top Line.
Beck is the Chief Development Officer at the company, which stands tall as a pioneer in specialty product distribution with over 40 years of experience dating back to hemophilia therapies.
During the conversation, Beck provides an inside look at the rapidly evolving specialty distribution landscape. He outlines how the patient-centric model is working well and is supported by efficient supply chains. However, the future will demand increasing personalization to handle a wider range of complex product archetypes like cell and gene therapies. This, Beck says, calls for expanded data capabilities around inventory visibility, site analytics and dissecting the patient journey.
Beck also goes on to explain how new regulations like the Inflation Reduction Act will impact specialty distribution, and why emerging manufacturers will increasingly rely on experienced partners like BioCare.
Don't miss this insightful discussion on meeting today's specialty distribution needs while paving the way for tomorrow's innovations.
Tune in now.
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This week on "The Top Line," we explore biopharma layoffs in the first quarter of 2024.
Using data from Fierce Biotech's layoff tracker, Gabrielle Masson and Max Bayer analyze the trends of layoffs in the first quarter of 2024, comparing them to previous years. With a notable number of layoff rounds marking the start of the year, they examine the factors behind this ongoing challenge while also highlighting positive industry developments.
To learn more about the topics in this episode:
- No reprieve for biopharma layoffs in Q1: Fierce Biotech analysis
- Fierce Biotech Layoff Tracker 2024
See omnystudio.com/listener for privacy information.
This week on “The Top Line,” we explore peripheral arterial disease, a serious health issue that is often overlooked and undermanaged.
Join Editor-in-Chief of Fierce Life Sciences and Healthcare Ayla Ellison as she sits down with Kumar Madassery, M.D., Director of the Peripheral Vascular Intervention & CLI Program at Rush University Medical Center. They discuss the hidden dangers of PAD, and Dr. Madassery emphasizes the importance of early detection. He also discusses the launch of the PAD Pulse Alliance, a collaborative effort among vascular health experts aimed at raising awareness, improving early detection and reducing amputation rates.
To learn more about the topics in this episode:
- Philips-supported campaign wants Americans to 'get a pulse on PAD' amid ignorance of the disease
- Johnson & Johnson 'Save Legs. Change Lives.' campaign brings PAD amputation awareness to Black community
- Bayer and J&J's Xarelto reduces ischemia risk for PAD patients after revascularization surgery
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This week on "The Top Line," we explore our annual special report on the top money raisers in the biotech industry.
Which company raised the most funding in 2023? What does the biotech financing landscape look like for this year? Fierce Biotech's Annalee Armstrong and Max Bayer answer those questions and many more in today's episode. They also discuss the details of the special report and share some of the stories behind the numbers.
To learn more about the topics in this episode:
- Biotech's top money raisers of 2023
- Fierce Biotech Fundraising Tracker 2024
- Fierce Biotech Fundraising Tracker 2023
See omnystudio.com/listener for privacy information.
This week on “The Top Line,” we explore the European biotech investment landscape.
Fierce Biotech’s James Waldron sits down with Maina Bhaman, a Partner at Sofinnova Capital Strategy, who provides insights into how investors are approaching the European biotech sector.
To learn more about the topics in this episode:
- 'The fundamentals are really strong': Why investors are staying loyal to European biotech in 2023
- 'Optimism' at Jefferies conference, but don't expect biotech IPO boost soon, says Sofinnova chair
See omnystudio.com/listener for privacy information.
This week on “The Top Line,” we’re diving into the topic of diversity in clinical trials, examining both the progress made and the ongoing work needed to ensure inclusivity.
In this episode, Fierce Biotech Senior Editor Annalee Armstrong engages in a conversation with Karen Correa, Ph.D., Head of Global Clinical Operations at Takeda and Executive Sponsor of Trial Diversity. Correa shares her insights into why it's imperative for pharmaceutical companies to adapt and prioritize diversity in their clinical trials, while also discussing the initiatives Takeda has undertaken in this area.
To learn more about the topics in this episode:
- Clinical trial diversity craters out to lowest level in 10 years, IQVIA finds
- ASCO, ACCC become latest to call for clinical trial diversity with 6 strategies for improving inclusion in cancer studies
- Digital Medicine Society rolls out initiative to improve diversity in clinical trials
- FDA's Richard Pazdur, sector leaders push for private-public partnership to boost DEI in cancer drug development
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In this week's episode of "The Top Line," join Conor Hale, Senior Editor of Fierce Medtech, and Andrea Park, Deputy Editor of Fierce Life Sciences, as they share the highlights of this year's Fierce Medtech Fierce 15.
To learn more about the topics in this episode:
- Fierce Medtech's Fierce 15 of 2023
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This week on “The Top Line,” we’re speaking with Jared Baeten, MD, Ph.D., Vice President, HIV Clinical Development, Gilead Sciences about how advancements in HIV treatment research have enabled individuals to lead longer and healthier lives by taking and staying on medication. Nevertheless, HIV persists as a significant public health challenge. To end the HIV epidemic, it is crucial to go beyond a biomedical approach and fully integrate social determinants of health into the collective response. Not everyone is achieving long-term success.
Long-term success involves meeting more than the United Nations’ goals of ending the epidemic by 2030. Treatment selection can help prioritize long-term outcomes from the very beginning. There are several other key factors for people with HIV and their healthcare providers to consider when assessing treatment choices, such as the resistance and safety profile of a treatment, drug-to-drug interaction potential, and comorbid conditions.
This podcast is brought to you by Gilead Sciences. Visit gileadhivtogether.com to learn more about Gilead’s unique collaborations worldwide and the work to help end the HIV epidemic.
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The FDA recently asked the six marketed CAR-T therapies to add a new boxed warning item on their labels to reflect the risk of secondary T-cell cancers. This decision follows an investigation into the new safety signal from postmarketing adverse event reports and clinical trials.
In today’s episode, Fierce Pharma’s Angus Liu talks with regulatory experts Mwango Kashoki, M.D., SVP, Global Head of Regulatory Strategy at Parexel, and Steve Winitsky, M.D., VP, Technical, Regulatory Strategy at Parexel, to understand the rationale behind the FDA’s decision and to discuss its implications for CAR-T candidates and their developers down the line.
To learn more about the topics in this episode:
- FDA wants classwide boxed warning on all commercial CAR-T therapies amid secondary cancer safety probe
- Amid high-profile CAR-T safety probe, FDA’s Peter Marks offers first glimpse at data under review
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This week on “The Top Line,” we explore the impact of environmental, social and governance measures, commonly known as ESG, on the pharmaceutical industry.
Fraiser Kansteiner of Fierce Pharma engages in a conversation with Jim Greffet, Head of ESG Strategy at Eli Lilly, to gain insights. Greffet makes a compelling business case for integrating ESG into the core of drugmakers' DNA. He also discusses Eli Lilly’s specific ESG initiatives, illustrating how these strategies connect to the company’s extensive history.
To learn more about the topics in this episode:
- Patient groups want pharma to improve on ESG—and are pushing for a seat at the table
- Setting sights on suppliers: How biopharma is tackling the environment in its ESG commitments
- Seeing green, AstraZeneca lays down £100M for 15-year renewable gas project in UK
- Gilead receives awards, pledges commitment to COVID, the environment and inclusion in 2023
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Gene editing’s therapeutic application has transitioned from hypothetical to reality, marked by the recent approval of a CRISPR-based therapy for sickle cell and beta thalassemia. In the wake of these developments, new biotech companies are springing up spurred by advancements that redefine what conditions might soon become treatable.
One contender in this rapidly changing landscape is Verve Therapeutics. This week on "The Top Line," Fierce Biotech’s Max Bayer sits down with the company’s CEO Sekar Kathiresan, M.D., to discuss how Verve intends to distinguish itself. They also chat about what drove Dr. Kathiresan to biotech after more than 20 years as a cardiologist and geneticist.
To learn more about the topics in this episode:
- Verve Therapeutics unveils its lead program—a one-and-done treatment for genetic high cholesterol
- Lilly beams up Verve gene therapy programs for $600M from deal-hungry Beam
- Verve shows base editing works in humans in first clinical data—and is punished by investors
- Verve's base editing hold lifted, starting a thaw on a regulatory blockade that sent peers ex-US
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This week on “The Top Line,” we explore the most anticipated drug launches of 2024. Editor-in-Chief Ayla Ellison engages in a conversation with Fierce Pharma Marketing Senior Editor Ben Adams about the drugs likely to launch this year with the most significant sales potential by 2028.
To learn more about the topics in this episode:
- Top 10 most anticipated drug launches of 2024
- BMS unwraps $14B deal for Karuna, adding a schizophrenia drug awaiting FDA OK
- Bristol Myers Squibb has targeted launch plan for ‘multi-billion-dollar opportunity’ in Karuna schizophrenia drug
- Meet Madrigal Pharmaceuticals, which wants to be your liver's No. 1 fan
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Should physicians consider the psychological status of patients more when developing and delivering treatment plans? What knowledge barriers are there to this? And how can these barriers be overcome?
These questions lie at the heart of what John Kane has been pursuing as a healthcare communications and education expert for more than 30 years.
As Managing Director of MedThink Communications, having run his own agency for 17 years, he works with the simple mission to "turn information into outcomes."
In this episode of The Top Line podcast, John explores the link between a proper understanding of psychological factors and likely success of treatments. The conversation then moves on to discussing some of the key challenges faced by the medical industry in leveling the playing field between biological and psychological knowledge. Effective education and communication, he says, are a fundamental part of any solution.
Want to hear more from John? Listen to the podcast today.
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In this episode, Dr. Beate Mueller-Tiemann, Chief Technology Officer at Cytiva, joins Fierce Life Sciences’s Stephanie Butler.
Having spent almost all of her career working within large pharmaceutical enterprises such as Sanofi and Bayer, Beate made the switch to Cytiva in the early part 2023.
Her role at Cytiva involves overseeing teams which create and bring high-quality products and innovative manufacturing and R&D processes closer to patients. Beate also keenly supports female talents through participation in mentoring programs. Additionally, she is a member of FiDAR, an association which seeks to increase the representation of women on German corporate boards.
During the conversation, Beate discusses her passion for technology and how her career has been defined by working with technology to bring innovation and treatments to patients and improve health outcomes. She also touches on the ongoing work Cytiva is engaged in, as well as the importance of collaboration in driving R&D progress.
Tune in to the podcast to learn more. Check out this year's Fierce 50 honorees: https://fierce50.fiercelifesciences.com/
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While generative AI has dominated the spotlight in the past year, machine learning programs have already been significantly impacting patients and physicians for several years. The question now arises: how will the emergence of programs like ChatGPT, coupled with increasing calls to scrutinize their safety, influence the adoption of new AI programs and diagnostics in healthcare?
This week on “The Top Line,” Fierce’s Conor Hale interviews Peter Shen, the North American head of digital health at Siemens Healthineers, to explore what developers and regulators can do to ensure transparency in medical AI. He also dives into how the field could potentially benefit from a 21st-century update to the Hippocratic Oath.
To learn more about the topics in this episode:
- 2024 forecast: Will generative AI find what it needs to deliver for patients?
- FDA to form advisory committee for digital health and AI
- US government to launch AI Safety Institute, develop standards for biotech R&D
- Biden to sign sweeping executive order pursuing 'safe, secure and trustworthy' AI development
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While it’s a known fact that women, on average, live longer than men, a recent report unveils a nuanced reality—women also spend more of their lives grappling with poor health.
This week on “The Top Line,” Ayla Ellison, editor-in-chief of Fierce Healthcare and Life Sciences, explores the root causes behind this disparity and the multifacted nature of the women’s health gap. She's joined by one of the lead authors of the report, Valentina Sartori, Ph.D., and a contributor to the report, Kelle Moley, M.D.
The report highlights that addressing the women’s health gap and investing in women’s health could inject $1 trillion into the economy annually by 2040, and Dr. Sartori explains why that number could be a significant underestimation.
While the report provides a clear understanding of the challenges, it also sheds light on viable pathways to close the women’s health gap and create a future where women not only live longer but lead healthier lives.
To learn more about the topics in this episode:
- Closing the women’s health gap: A $1 trillion opportunity to improve lives and economies
- White House launches new initiative aimed at investing in women's health research
- Organon finally offers a larger pharma model for women's health. But 'one company can't do it by itself'
- CMS unveils new model to support Medicaid agencies in offering whole-person maternal health
- Menopause care is still a largely untapped market. Here's why investors and startups should dive in
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At Fierce Pharma, the arrival of a new year is synonymous with the release of our annual special report on drug approvals. This week on “The Top Line,” Fierce Pharma’s Eric Sagonowsky and Kevin Dunleavy, both instrumental in creating the special report, are breaking down the numbers and sharing key insights into the landscape of drug approvals in 2023.
To learn more about the topics in this episode:
- 2023 drug approvals: After a down year, FDA signs off on a bounty of new meds, including 7 from Pfizer
- 2022 drug approvals: After Aduhelm fiasco, FDA endorsements drop to 37
- 2021 drug approvals: In a year dominated by COVID, biopharma managed to deliver 55 new drugs
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This week on "The Top Line," Fierce Biotech staff writer Gabrielle Masson and senior editor Annalee Armstrong look back at the year in biotech, which was defined by massive layoffs across the industry. They also discuss their favorite stories of the year, including an appearance from a popstar whose reputation precedes her.
To learn more about the topics in this episode:
- Biotechs end year 'trading for nothing' as investors mull 'what is IPO-able today?'
- Fierce Biotech Layoff Tracker 2023
- Editor's Corner—When ASCO dueled with the world's biggest pop star, Swift Biotech was ready for it
- Alzheimer's meds are here. But for the Down syndrome community, it's still the 1980s
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Paul Beresford and Lou Welebob of Agilent Technologies discuss how partnerships are vital in addressing the evolving needs of pharma for complex diagnostics and CDx development.
Discussions center around the importance of working with pharmaceutical companies to drive medical innovation and improve patient outcomes, helping to speed up the process of bringing the right treatments to the right patients at the right time.
Topics discussed include the importance of broadening technological focus on immunohistochemistry, such as bridging into digital biology and imaging as well as multiplexing. Spatial biology is touched upon, specifically looking at how spatial profiling can be used to determine cell proximity within the tumor microenvironment, potentially correlated to drug efficacy.
Looking ahead, both speakers point to the potential to use machine learning in key areas such as the development of assays for use across laboratories globally.
To discover the full range of insights from life sciences, diagnostics and applied chemical markets specialist Agilent Technologies, listen to the full podcast.
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Earlier this year, Fierce Healthcare, Fierce Pharma and Fierce Biotech recognized 50 individuals and companies that are pushing the industry forward. The Fierce 50 honorees range from tech innovators to researchers developing novel therapies to providers on the frontlines of changing care. This week on "The Top Line," senior editor Paige Minemyer sat down with staff writers Dave Muoio and Anastassia Gliadkovskaya as well as senior editor Heather Landi to discuss a few of the honorees in more detail.
To learn more about the topics in this episode:
- The Fierce 50 of 2023
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The antifungal agent Amphotericin B is highly effective against a wide range of deadly fungi and resistance is rare, even after decades of use. But it comes with a virtual guarantee of kidney damage, earning it the nickname “Ampho-terrible.”
Now, a better alternative might be on the way. Fierce Biotech Research’s Helen Floersh spoke with Martin Burke, M.D., Ph.D., a chemistry professor and researcher at the University of Illinois and the founder of antifungal startup Sfunga Therapeutics, to get the story behind the new drug’s design, its path to the clinic and how it could influence the next generation of antimicrobials.
To learn more about the topics in this episode:
- Potent new drug has all the power of nature's strongest antibiotic, without the toxicity
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In this episode of "The Top Line," we're highlighting the remarkable women featured in our annual Fiercest Women in Life Sciences special report. The list comprises 10 trailblazers changing the leadership landscape in pharma, biotech and medtech. Join Deputy Editor Andrea Park and Senior Editor Annalee Armstrong as they reflect on the inspiring stories of the women who made this year’s list.
To learn more about the topics in this episode:
- 2023's Fiercest Women in Life Sciences
- The Fierce 50 of 2023
- Fierce 50 Awards Gala
See omnystudio.com/listener for privacy information.
This episode of "The Top Line" is dedicated to Alzheimer’s disease, exploring the latest treatments and what lies ahead.
In the first segment, Fierce Pharma’s Fraiser Kansteiner engages in a conversation with Alexander Scott, senior vice president of integrity at Eisai, to discuss the full approval of Leqembi and what it means for Eisai and, most importantly, for Alzheimer's patients.
Next, Fierce Biotech’s Annalee Armstrong interviews Howard Fillit, M.D., an expert in the field of Alzheimer's research and the co-founder and chief science officer at the Alzheimer's Drug Discovery Foundation. They explore the pioneering work being done in Alzheimer's research and discuss the latest breakthroughs.
In the third segment, Fierce Pharma’s Eric Sagonowsky talks with Reisa Sperling, M.D., who is leading a research team investigating whether Leqembi holds promise in preventing disease progression before any Alzheimer’s symptoms are evident.
To learn more about the topics in this episode:
- With full Alzheimer's approval in hand, Eisai and Biogen kick off Leqembi's launch in earnest
- After winning full FDA nod for Leqembi, Eisai touts 'promising' study on subcutaneous version
- Eisai, Biogen's Leqembi may face rollout hurdles now, but experts still like the Alzheimer's drug
- Eisai launches 'digital business' Theoria to build out a dementia ecosystem for patients
- Eisai, Biogen's injectable Leqembi clears toxic protein in Alzheimer's disease. What about safety?
- Experimental Alzheimer's molecule improves cognition in mice by tamping down on inflammation
- Voyager Therapeutics adds anti-amyloid gene therapy to Alzheimer's pipeline
- Acumen's stock surges as early Alzheimer's data suggest next-gen Leqembi rival is active
See omnystudio.com/listener for privacy information.
In this episode of “The Top Line,” we explore the next potential wave of mental health therapy: psychedelics.
Fierce Biotech's Max Bayer sits down with Scott Aaronson, M.D., a seasoned clinician and psychiatrist with over 30 years of experience in the field. They discuss how psychedelics might be used in the treatment of conditions such as depression, substance addiction, PTSD, anorexia, and more. They also examine the obstacles developers face as they advance their studies.
To learn more about the topics in this episode:
- MDMA approval filing nears after drug hits again in phase 3, showing consistent PTSD improvements
- Early clinical data on psilocybin in anorexia point Compass to potential new opportunity
- Otsuka adopts new Mindset, dropping $59M to buy Canadian psychedelic biotech
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While the new Alzheimer’s disease medicine Leqembi has generated lots of buzz since its debut this year, one research team is investigating whether the medicine holds promise in preventing disease progression before any Alzheimer’s symptoms are evident.
In this week's episode of "The Top Line," Fierce Pharma’s Eric Sagonowsky talks with the study lead, Reisa Sperling, M.D., to learn more.
To learn more about the topics in this episode:
- Eisai, Biogen's injectable Leqembi clears toxic protein in Alzheimer's disease. What about safety?
- 'The Top Line': Leqembi's full approval and the future of Alzheimer's treatment
- With full Alzheimer's approval in hand, Eisai and Biogen kick off Leqembi's launch in earnest
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In this episode of “The Top Line,” we delve into the FDA's controversial approval of Aduhelm, a drug for Alzheimer's disease, despite an independent advisory committee's resounding rejection. The decision has sparked questions about potential bias within the regulatory body.
Genevieve Kanter, Ph.D., a professor at the USC Sol Price School of Public Policy, joins Fierce's Kevin Dunleavy to discuss the implications of a study published in July in JAMA Health Forum, which found the FDA's propensity to favor positive panel recommendations. They explore the impact of this potential bias on drug development and public health.
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In this episode of "The Top Line," Fierce's Fraiser Kansteiner engages in a conversation with Alexander Scott, senior vice president of integrity at Eisai, to discuss the full approval of Leqembi and what it means for Eisai and, most importantly, for Alzheimer's patients.
To learn more about the topics in this episode:
- With full Alzheimer's approval in hand, Eisai and Biogen kick off Leqembi's launch in earnest
- After winning full FDA nod for Leqembi, Eisai touts 'promising' study on subcutaneous version
- Eisai, Biogen's Leqembi may face rollout hurdles now, but experts still like the Alzheimer's drug
- Eisai launches 'digital business' Theoria to build out a dementia ecosystem for patients
See omnystudio.com/listener for privacy information.
In this episode of "The Top Line," Fierce Biotech's Annalee Armstrong engages in a conversation with Howard Fillit, M.D., an expert in the field of Alzheimer's research and the co-founder and chief science officer at the Alzheimer's Drug Discovery Foundation.
They delve into the pioneering work being done in Alzheimer's research, discuss the latest breakthroughs, and explore the ongoing efforts to combat this complex disease.
To learn more about the topics in this episode:
- With full Alzheimer's approval in hand, Eisai and Biogen kick off Leqembi's launch in earnest
- Eisai, Biogen's Leqembi may face rollout hurdles now, but experts still like the Alzheimer's drug
- Experimental Alzheimer's molecule improves cognition in mice by tamping down on inflammation
- Voyager Therapeutics adds anti-amyloid gene therapy to Alzheimer's pipeline
- Acumen's stock surges as early Alzheimer's data suggest next-gen Leqembi rival is active
See omnystudio.com/listener for privacy information.
“Essentially, this allows our clinical researchers to improve the chances of success for the trial leading to faster, more efficient drug development… Ultimately, this is going to benefit patients.”
Greg Lever is speaking about the use of flexible modeling to allow real-time changes to be made to clinical trial design and processes.
As a Director within the IQVIA Applied Data Science Center, and with over a dozen years of experience in the field, Greg knows the importance of data and advanced analytics in generating accurate patient insights to underpin key trial decision-making.
By making clinical trials more patient friendly, he states, the more likely it is that research organizations will be able to attract and retain the participants they need to bring life-saving treatments to patients.
In this podcast, Greg outlines how modeling can be used to enhance the entire patient journey, from the initial giving of informed consent right through to the trial’s close.
Host: Julia Douthart
Producer: Matt Rickman
Sponsored by IQVIA
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In this episode of "The Top Line," we delve into the uncharted territory that pharma marketers face, from harnessing AI's potential to navigating the Inflation Reduction Act. Ayla Ellison, editor-in-chief of Fierce Life Sciences and Healthcare, engages with three industry experts to unravel the opportunities and challenges that lie ahead.
In the first segment, Robert Allen, the leader behind engagement and channel planning for U.S. Oncology at Bristol Myers Squibb, shares his insights into strategic planning for customer engagement and channel strategies. Next, Terry Terifay, the Chief Commercial Officer at Azurity Pharmaceuticals, offers a glimpse into what the future holds for the industry. In the third segment, Dorothy Gemmel, the Chief Commercial Officer of GoodRx, shares the projects she's excited about and her biggest piece of advice for others in the industry."
To learn more about the topics in this episode:
- Will Big Pharma engage in Medicare price negotiations? Merck, AZ and BMS say they will
- Providers can now see patients' insurance coverage in GoodRx's cost comparison tool
- Bristol Myers banks on 25-plus label expansions to help weather IRA, Revlimid generics and more
- GoodRx, Walgreens team to lower prices for 200 drugs
- Fierce Pharma unveils the winners of the 5th annual creativity contest for outstanding marketing campaigns
See omnystudio.com/listener for privacy information.
AstraZeneca has made several news headlines for its environmental sustainability pledges, including deals for renewable natural gas and a commitment to plant hundreds of millions of trees.
In this episode of "The Top Line," Fierce Pharma's Eric Sagonowksy talks with Pam Cheng, the AstraZeneca executive who is playing a key role in driving the company's sustainability ambitions.
To learn more about the topics in this episode:
- Fellowship of the green: AstraZeneca, Samsung, GSK and more unite to slash greenhouse gas emissions
- AstraZeneca sows $400M investment in push to plant 200M trees by 2030
- From farm to pharma: AstraZeneca inks renewable natural gas pact to shrink environmental footprint
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In this episode of "The Top Line," Annalee Armstrong and Gabrielle Masson shine a spotlight on some of the most promising companies in the biotech world. Additionally, you'll have the opportunity to hear from Kevin Dunleavy as he engages in a conversation with Ray Pressburger from Accenture, discussing drug commercialization and the models that are proving to be the most effective.
See omnystudio.com/listener for privacy information.
In this episode of "The Top Line," our Fierce reporters tackle topics like the trends we saw at Cannes Lions, the cancer drug shortage, and the top compensated CEOs in the industry.
To learn more about the topics in this episode:
- National cancer group reports widespread chemo shortages, calls on government and industry to help resolve them
- FDA to allow temporary overseas production to shore up supplies of chemo drug
- FDA can't solve drug shortages on its own, agency's oncology chief says
- Play it loud: Cannes winner pitches sound therapy as extra tool in arsenal against cancer
- How Eversana roared back from rejection to craft Cannes-winning campaign hospitals couldn't ignore
- In a year of turnover, Seagen doled out $126M to a trio of CEOs
- The 15 highest paid pharma CEOs of 2021
- UPDATED: Moderna CEO Stéphane Bancel earned $19.4M in 2022 but made much more in stock sales
"The Top Line" and "Podnosis" are produced by senior podcast producer Teresa Carey. The stories are by all our “Fierce” journalists. Like and subscribe wherever you listen to your podcasts.
See omnystudio.com/listener for privacy information.
In this episode of "The Top Line," Teresa Carey talks with Dr. Sebastian Ocklenburg, Department of Psychology at MSH Medical School Hamburg, Germany, about how significant left-handedness is to clinical research. It is International Left-Hander's Day, so we dive deep into understanding brain hemisphere asymmetry and its significance in the context of neurodevelopmental and psychiatric disorders.
"The Top Line" and "Podnosis" are produced by senior podcast producer Teresa Carey. The stories are by all our “Fierce” journalists. Like and subscribe wherever you listen to your podcasts.
See omnystudio.com/listener for privacy information.
In this episode of "The Top Line," Zoey Becker talks with Dr. Andrew Norden, Chief Medical Officer at OncoHealth, about the ongoing chemotherapy shortage sweeping the nation and what oncologists and health insurance companies can do to best support patients amidst these supply chain issues.
We also cover the a single-injection treatment for sickle cell disease, battery-powered gene therapy, and the rest of the week's headlines.
To learn more about the topics in this episode:
- National cancer group reports widespread chemo shortages, calls on government and industry to help resolve them
- FDA to allow temporary overseas production to shore up supplies of chemo drug
- FDA can't solve drug shortages on its own, agency's oncology chief says
- FDA links 4 deaths to recalled Abiomed Impella pumps after TAVR collisions
- Quest launches blood test for Alzheimer's disease aimed at general consumers
- One injection to cure sickle cell? Researchers give it a shot with new mRNA gene therapy
- With 3 AA batteries and 2 acupuncture needles, a device controls gene expression in live mice
"The Top Line" and "Podnosis" are produced by senior podcast producer Teresa Carey. The stories are by all our “Fierce” journalists. Like and subscribe wherever you listen to your podcasts.
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In this episode of 'The Top Line' we reply an important show from April 28, 2023 regarding Narcan.
On March 29th, the FDA approved the Narcan nasal spray for over-the-counter sales. It is the first naloxone product approved for use without a prescription. In this episode of The Top Line, Fierce Pharma staff writer Fraiser Kansteiner launches a mini-series to explore what that means for the opioid epidemic. The series will tackle questions about using the product, its accessibility and whether the move will save lives.
To learn more about the topics in this episode:
- Emergent makes history with first FDA nod for over-the-counter naloxone
- Teva, Sandoz have launched Narcan generics, but Emergent's branded option should still thrive: analysts
- Adapt tests ads urging opioid users' loved ones to stock Narcan at home
- Eyeing $1B in annual sales, Emergent BioSolutions to buy Narcan maker Adapt for $735M
- Ahead of next month's FDA decision, Emergent aces AdComm for over-the-counter Narcan nod
The Top Line is produced by senior podcast producer Teresa Carey. The stories are by all our “Fierce” journalists. Like and subscribe wherever you listen to your podcasts.
See omnystudio.com/listener for privacy information.
In this episode of "The Top Line," we talk with Dr Reanne Moore, an associate professor of psychiatry at the University of California San Diego, about the state of digital phenotyping. We also cover the vaccine patent lawsuits, the smallest insulin pump, and the rest of the week's headlines.
To learn more about the topics in this episode:
- Nominations for Fierce Biotech's 2023 Fierce 15 close Friday—three more days to submit
- The Future of Biotech
- ADC puts Zynlonta study on hold after 7 patient deaths, 5 other severe adverse events
- Tandem crosses FDA finish line with nod for miniaturized insulin pump
- Moderna mounts 2 new patent lawsuits against mRNA rivals Pfizer, BioNTech: report
- Novartis retreats from TIGIT, handing $300M candidate back to BeiGene
- Illumina receives record €432M fine from EU for false start on Grail deal
"The Top Line" is produced by senior podcast producer Teresa Carey. The stories are by all our “Fierce” journalists. Like and subscribe wherever you listen to your podcasts.
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For sponsors, value lies in equipping sites with the technology that makes securely capturing pre-screening, recruitment, and enrollment data easier.
In this interview, Alicia Asgari, the Senior Manager of Solutions Consulting at OneStudyTeam, discusses the need for appropriate technology solutions and strategies for sponsors and sites to solve recruitment and enrollment challenges. OneStudyTeam is a provider of cloud-based software and enrollment solutions for sponsors, sites, and CROs with the mission to accelerate the development of new and lifesaving therapies.
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In this episode of "The Top Line," we talk with ViiV’s head of R&D, Dr. Kimberly Smith, about new HIV therapies. We also cover Humira's new biosimilar, foreign pharmaceutical investments, and the rest of the week's headlines.
To learn more about the topics in this episode:
- Explore the categories of the Fierce 50
- AstraZeneca stock slides as pivotal lung cancer readout on Daiichi-partnered ADC spooks investors
- Boehringer Ingelheim launches first interchangeable biosimilar to AbbVie's Humira
- Moderna strikes deal worth up to $1B to develop, produce mRNA drugs in China: reports
- GSK's ViiV explores novel pathway to bring long-acting HIV med Cabenuva to tough-to-treat patients
"The Top Line" is produced by senior podcast producer Teresa Carey. The stories are by all our “Fierce” journalists. Like and subscribe wherever you listen to your podcasts.
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In this episode of "The Top Line," we talk with Fierce’s Andrea Park and Gabrielle Masson about the latests from the American Diabetes Association's annual conference. We also cover plus a statement about transgender care, light therapy, and the rest of the week's headlines.
To learn more about the topics in this episode:
- 'Podnosis': Medicaid eligibility determinations, healthcare for the LGBTQ+ community
- Introducing the Fierce 50: Honoring healthcare and biopharma champions fighting for patient care
- Lilly links oral obesity drug to 15% weight loss, setting bar for Pfizer in blockbuster battle
- Boehringer's new data drop shows 19% weight loss for phase 2 obesity prospect
- UPDATE: Lilly's next obesity drug just cut an average of 58 pounds—prompting an all-out phase 3 blitz
- Let there be light: Scientists report new progress in quest to treat afib with optogenetics
- UK's flagging clinical trial sector faces fresh challenge as National Cancer Research Institute set to close
- Biotech leaders protest 'actively harmful' bans on gender-affirming care
- Know Labs unveils first prototype of portable, noninvasive glucose monitor
- Embecta dives deeper into Type 2 diabetes tech with Tidepool team-up
- Fitterfly's diabetes digital therapeutic cuts blood sugar, weight in real-world trial
"The Top Line" is produced by senior podcast producer Teresa Carey. The stories are by all our “Fierce” journalists. Like and subscribe wherever you listen to your podcasts.
We’d love to hear from you! If you have a comment about this podcast or if you have a tip for a future episode of The Top Line, you can reach us at this link.
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In this episode of "The Top Line," we talk with Fierce’s Eric Sagonowsky and Kevin Dunleavy about the most expensive drugs in the U.S. We also cover Eli Lilly's recent acquisition, the latest company to challenge the Inflation Reduction Act, and the rest of the week's headlines.
To learn more about the topics in this episode:
- 'Misinformation': AstraZeneca's China head refutes news report about potential spinoff
- Deadline extended: Biopharma's collective memory of COVID—in photographs
- Lilly makes fresh bet on IL-17 with $2.4B acquisition of Dice Therapeutics
- Bristol Myers follows Merck's lead with its own lawsuit blasting IRA's Medicare negotiations
- Most expensive drugs in the US in 2023
"The Top Line" is produced by senior podcast producer Teresa Carey. The stories are by all our “Fierce” journalists. Like and subscribe wherever you listen to your podcasts.
See omnystudio.com/listener for privacy information.
In this episode of "The Top Line," we talk with Fierce’s Max Bayer and Angus Liu about the most important news coming from this year's annual BIO conference. We also cover a COVID lawsuit, an FDA-approved app, and the rest of the week's headlines.
To learn more about the topics in this episode:
- ASCO: After lung cancer fails, Roche's faith in TIGIT rewarded as tiragolumab shows signs of life in liver cancer
- Merck ends last Keytruda trial in aggressive prostate cancer campaign, takes separate hit in lung cancer
- Roche, with HER2 franchise under pressure, pays $70M for breast cancer brain metastases prospect
- Takeda pledges up to $1.13B for rights to Hutchmed's cancer drug fruquintinib outside of China
- BIO: Moderna to test mpox vaccine in humans this summer
- BIO: Jazz is auditioning new bandmates in an M&A market ripe with talent
- BioNTech to defend itself against COVID-19 vaccine injury claim in Germany
- Salvation or 'death warrant'? Erytech's war with activist investor rumbles on as merger vote nears
- RSV vaccine awareness low among older adults, but majority would ask their doc about new shots: survey
- Huma nabs FDA nod for AI-backed disease management platform
- Medtronic warns cardioversion can fry some Vanta neurostimulators
"The Top Line" is produced by senior podcast producer Teresa Carey. The stories are by all our “Fierce” journalists. Like and subscribe wherever you listen to your podcasts.
See omnystudio.com/listener for privacy information.
In this episode of the "The Top Line," we talk with Fierce’s Gabrielle Masson and Andrea Park about the most important news coming from this year's annual ASCO meeting. We also cover contesting the Inflation Reduction Act, an ADHD video game, and the rest of the week's headlines.
To learn more about the topics in this episode:
- ASCO: Novocure's tumor-treating electric fields nearly double survival for some lung cancer patients
- ASCO: Astellas exec jokes that 3 pending drug approvals are turning his hair gray
- ASCO: J&J's multiple myeloma combo produces déjà vu with 96% Carvykti-like response
- ASCO: Illumina's oncology exec on the need to 'democratize genomic profiling in cancer'
- Merck challenges HHS on Medicare drug price negotiations, alleging violations of the Constitution
- Akili launches over-the-counter version of attention-improving video game for adults with ADHD
- FDA document outlines apparent agency support for full approval of Biogen, Eisai's Leqembi
"The Top Line" is produced by senior podcast producer Teresa Carey. The stories are by all our “Fierce” journalists. Like and subscribe wherever you listen to your podcasts.
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Victoria Summers is a principal at ZS and the East Coast lead for the company’s patient health and equity accelerator. She is also used to being on the other side of the mic, hosting the company’s own podcast that focuses on the issue of patient centricity.
Victoria tackles a range of questions and discussion points around the subject of patient engagement and how the industry can and should reach out to the people who rely on their solutions.
How should information be communicated? How does communication and patient outreach tie into the ongoing and pressing challenge of promoting health equity? Will better engagement lead to the creation of more effective solutions?
These are just some of the discussion points touched on in this episode. Tune in to discover Victoria’s take on these issues, and more.
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In this episode of the "The Top Line," Fierce’s Anastassia Gliadkovskaya talks with Autumn Ehnow, vice president of Medicines360, a nonprofit pharma with a mission to produce and sell affordable medications. They talk about the need to democratize access to medications like emergency contraception, particularly for women. We also cover Elizabeth Holmes, the state of Alzheimer's research, plus more headlines.
To learn more about the topics in this episode:
- Startup Curae Pharma360 partners with Direct Relief to distribute free contraceptives to safety-net clinics
- CMS proposes rules to expand access to contraception under ACA
- HHS warns retail pharmacies to not curb access to birth control, abortion pill prescriptions
- Hunt for new non-hormonal birth control sends scientists under the sea
- FDA can't solve drug shortages on its own, agency's oncology chief says
- Theranos' Elizabeth Holmes reports to Texas prison to begin 11-year sentence
- The Alzheimer's pipeline is as strong as ever. Now, we just need the patients
- Small biotech turns CRISPR against bacteria, reducing E. coli in small early study
"The Top Line" is produced by senior podcast producer Teresa Carey. The stories are by all our “Fierce” journalists. Like and subscribe wherever you listen to your podcasts.
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In this episode of the "The Top Line," Fierce Pharma's Fraiser Kansteiner and Eric Sagonowsky discuss the 20 most influential people in biopharma. We also cover a new topical gene therapy from Krystal Biotech, the FDA approval of Brixadi to treat patients with opioid use disorder, plus more headlines.
To learn more about the topics in this episode:
- The most influential people in biopharma in 2023
- FDA clears Braeburn's long-acting Brixadi to treat opioid use disorder
- Krystal's Vyjuvek becomes first topical gene therapy with FDA nod to treat rare skin disease
- Novo Nordisk pauses Wegovy marketing projects to dampen demand
- It's time for Fierce Biotech's 2023 Fierce 15—nominations are NOW OPEN
"The Top Line" is produced by senior podcast producer Teresa Carey. The stories are by all our “Fierce” journalists. Like and subscribe wherever you listen to your podcasts.
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Layoffs have hit biopharma hard over the last year and a half. In this episode Fierce's Max Bayer and Gabrielle Mason will discuss the recent trends. We'll also cover a gene therapy by Sarepta Therapeutics, Abbott's FDA approval, plus this week's headlines.
To learn more about the topics in this episode:
- Layoffs continue to batter biotech, with Big Pharmas piling on the pain
- Abbott's spinal cord stimulators score FDA approval to treat nonsurgical back pain
- Theranos' Elizabeth Holmes ordered to report to prison amid appeal, fined $452M in restitution alongside Sunny Balwani
- UPDATED: FTC sues to block Amgen's $28B Horizon buy in alarming sign for biopharma M&A
- UPDATED: FDA advisers narrowly vote in favor of Sarepta's DMD gene therapy
"The Top Line" is produced by senior podcast producer Teresa Carey. The stories are by all our “Fierce” journalists. Like and subscribe wherever you listen to your podcasts.
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On March 29, the FDA approved the Narcan nasal spray for over-the-counter sales. It is the first naloxone product approved for use without a prescription. In this episode of "The Top Line," Fierce Pharma staff writer Fraiser Kansteiner concludes our miniseries to explore what that means for the opioid epidemic. We'll also cover a possible over-the-counter birth control, a COVID test recall, plus this week's headlines.
To learn more about the topics in this episode:
- Lilly's hotly anticipated Alzheimer's data set a new high score in slowing cognitive decline
- Baxter breaks off biopharma solutions segment in $4.25B private equity deal
- Let's make a deal: Conditions are right for biopharma M&A to break out, analysts say
- Roche, SD Biosensor recall 500,000 at-home COVID tests due to bacteria risks
- Perrigo's OTC birth control pill aces FDA expert meeting
- Emergent makes history with first FDA nod for over-the-counter naloxone
- Ahead of next month's FDA decision, Emergent aces AdComm for over-the-counter Narcan nod
"The Top Line" is produced by senior podcast producer Teresa Carey. The stories are by all our “Fierce” journalists. Like and subscribe wherever you listen to your podcasts.
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Dr. Christopher Piorkowski, Divisional Vice President and Chief Medical Officer of Abbott's Electrophysiology business, is the latest guest on The Top Line podcast.
A seasoned expert in the field of electrophysiology, he joins us to discuss and explain some of Abbott’s latest solutions and advancements, as well as best practices to support treatment for abnormal heart rhythms.
EnSite X, for example, is Abbott’s revolutionary 3D heart mapping software which Piorkowski describes as the company's most important product development of the past decade and compares it to the transition from a gasoline to an electric car in terms of its implications.
And it is easy to see why. EnSite X acts as an ultra-accurate GPS system that helps physicians to locate and understand the areas in a patient’s heart needing ablation. A significant update has been the incorporation of near field technology – this helps physicians to understand which of the electrical signals that they see on the catalyst is truly from the location of a catheter, as opposed to signals that come from further away in so-called far field signals.
The discussion also takes a turn towards pulsed field ablation, something which Abbott has been working with for well over a decade.
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On March 29th, the FDA approved the Narcan nasal spray for over-the-counter sales. It is the first naloxone product approved for use without a prescription. In this episode of The Top Line, Fierce Pharma staff writer Fraiser Kansteiner continues our mini-series to explore what that means for the opioid epidemic. The series will tackle questions about using the product, its accessibility and whether the move will save lives.
To learn more about the topics in this episode:
- Emergent makes history with first FDA nod for over-the-counter naloxone
- Teva, Sandoz have launched Narcan generics, but Emergent's branded option should still thrive: analysts
- Adapt tests ads urging opioid users' loved ones to stock Narcan at home
- Eyeing $1B in annual sales, Emergent BioSolutions to buy Narcan maker Adapt for $735M
- Ahead of next month's FDA decision, Emergent aces AdComm for over-the-counter Narcan nod
- Virtual Roundtable: Remote Therapeutic Monitoring, The Future of Virtual Care Management
The Top Line is produced by senior podcast producer Teresa Carey. The stories are by all our “Fierce” journalists. Like and subscribe wherever you listen to your podcasts.
See omnystudio.com/listener for privacy information.
On March 29th, the FDA approved the Narcan nasal spray for over-the-counter sales. It is the first naloxone product approved for use without a prescription. In this episode of The Top Line, Fierce Pharma staff writer Fraiser Kansteiner launches a mini-series to explore what that means for the opioid epidemic. The series will tackle questions about using the product, its accessibility and whether the move will save lives.
To learn more about the topics in this episode:
- Emergent makes history with first FDA nod for over-the-counter naloxone
- Teva, Sandoz have launched Narcan generics, but Emergent's branded option should still thrive: analysts
- Adapt tests ads urging opioid users' loved ones to stock Narcan at home
- Eyeing $1B in annual sales, Emergent BioSolutions to buy Narcan maker Adapt for $735M
- Ahead of next month's FDA decision, Emergent aces AdComm for over-the-counter Narcan nod
The Top Line is produced by senior podcast producer Teresa Carey. The stories are by all our “Fierce” journalists. Like and subscribe wherever you listen to your podcasts.
See omnystudio.com/listener for privacy information.
2022 was the third straight year where the coronavirus pandemic had an extreme effect on the revenue of several biopharma companies. Pfizer became the first company in industry history to rack up more than 100 billion dollars in sales. We discuss how other companies fared in 2022 and what we can expect this year.
To learn more about the topics in this episode:
- The top 20 pharma companies by 2022 revenue
- Big Pharmas finally strike with GSK, Merck acquisitions, signaling accelerating pace of M&A
- Merck & Co. inks $11B Prometheus takeover, firing starting gun on race for blockbuster bowel market
- GSK coughs up $2B to buy Bellus for late-phase rival to Merck & Co.'s stuttering gefapixant
- Medtronic embarks on monthslong global layoffs, with total cuts unknown
- Eli Lilly adds $1.6B to its manufacturing spending plan in Indiana, breaking a company record
- J&J, Legend's Carvykti cut risk of progression or death by whopping 74% in earlier myeloma, leaked abstract shows
The Top Line is produced by senior podcast producer Teresa Carey. The stories are by all our "Fierce" journalists. Like and subscribe wherever you listen to your podcasts.
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Fierce Biotech regularly pulls together the industry’s top money raisers from the year before. Staff writer Gabrielle Masson and Editor-in-Chief Ayla Ellison discuss a few of the biotechs at the top of the list.
Plus, in this episode, we cover Johnson & Johnson's talc litigation, prison plans for Elizabeth Holmes and more of this week's top headlines.
To learn more about the topics in this episode:
- Biotech's top money raisers of 2022
- Johnson & Johnson's $8.9B bankruptcy settlement is 'unworkable,' talc plaintiff lawyer says
- Theranos' Elizabeth Holmes must report to prison this month despite pending appeal, judge rules
- FDA dubs Abbott's FreeStyle Libre battery issues a Class I recall, spanning 4.2M devices
- Philips re-recalls 1,200 CPAP, BiPAP machines repaired in far-reaching ventilator probe
- Activist investor Icahn calls for Illumina CEO to be voted off company board over Grail deal
- Moderna's mRNA flu shot struggles to prove its worth again in phase 3 trial
- Sanofi's Provention buyout hit with FTC delay. Will Pfizer's Seagen deal go off as planned?
- After last year's cuts, Biogen kicks off another round of layoffs
The Top Line is produced by senior podcast producer Teresa Carey and managing editor Querida Anderson. The sound engineer is Caleb Hodgson. The stories are by all our “Fierce” journalists. Like and subscribe wherever you listen to your podcasts.
See omnystudio.com/listener for privacy information.
For a long time, AbbVie’s Humira was the world’s top-selling drug. But the bestseller will finally face biosimilar competition. Plus, this year is also chock-full of other big-name, blockbuster drugs headed for the patent cliff. In this episode, we discuss 2023's patent story.
Plus, we cover how Johnson & Johnson is looking to end its talc litigation with a sweeping settlement and more of this week's top headlines.
To learn more about the topics in this episode:
- The top 10 drugs losing US exclusivity in 2023
- J&J proposes $8.9B talc settlement deal but some plaintiffs decry 'woefully inadequate' offer
- FTC reverses course, orders Illumina to unravel Grail deal
- Cytokinetics' pipeline tumble continues after ALS med flops in phase 3 interim look
- Ahead of Pfizer buyout, Seagen's Padcev gains Keytruda combo nod in first-line bladder cancer
- Butterfly nets AI ultrasound clearance for spotting signs of lung disease
- Intra-Cellular crowned your winner of the Fierce Madness Drug Ad Tournament 2023
"The Top Line" is produced by senior podcast producer Teresa Carey and managing editor Querida Anderson. The sound engineer is Caleb Hodgson. The stories are by all our “Fierce” journalists. Like and subscribe wherever you listen to your podcasts.
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2022 was a tough year for biotechs in anyone’s book. At Fierce, we recorded 119 companies that resorted to laying off staff. And judging by the Fierce Biotech Layoff Tracker, 2023 is looking like more of the same. Fierce Biotech’s James Waldron sat down with Glenn Hunzinger, the U.S. pharma and life science leader at PwC, to talk about the financial trends he expects biotechs to face in 2023.
Plus, in this episode, we cover Emergent's Narcan over-the-counter approval, the first PTSD neuromodulation device approval and more of this week's top headlines.
To learn more about the topics in this episode:
- We have achieved peak biotech formation. It's time for 'musical chairs'
- 'Stay alive': Wave of layoffs crashes into biotech startup inferno
- Fierce Biotech Layoff Tracker 2023: Alector sends home 11%; Ferring closes US research institute
- Fierce Biotech Fundraising Tracker '23: OncoVerity tacks on $30M from argenx, Univ. of Colorado; Sonoma nabs $30M Regeneron investment
- Fierce Biotech Layoff Tracker: Layoffs strike 119 companies in 2022
- Fierce Biotech Fundraising Tracker: Enlaza launches with $61M; Enveda brings in $68M
- Emergent makes history with first FDA nod for over-the-counter naloxone
- Neuromodulation device for PTSD treatment from GrayMatters snags FDA nod
- Musk's Neuralink seeks a clinical trial partner as it awaits FDA go-ahead: Reuters
- J&J scraps late-stage RSV vaccine in R&D overhaul, dropping out of race with GSK, Pfizer
- Look out, Lilly. Novartis touts 'consistent benefit' for Kisqali in broad early-stage breast cancer
- From cell therapies to US-made ingredients, White House outlines new drug manufacturing goals
The Top Line is produced by senior podcast producer Teresa Carey and managing editor Querida Anderson. The sound engineer is Caleb Hodgson. The stories are by all our “Fierce” journalists. Like and subscribe wherever you listen to your podcasts.
See omnystudio.com/listener for privacy information.
This year kicks off the second decade of Fierce Medtech’s annual Fierce 15 report. Not surprisingly, the startups featured on this year’s list are raising the bar for medtech developers everywhere. Staff writer Andrea Park and Editor-in-Chief Ayla Ellison discuss a few of the 15 startups that made the cut.
Plus, in this episode, we cover Illumina and Carl Icahn's proxy battle, Sanofi slashing insulin prices and more of this week's top headlines.
To learn more about the topics in this episode:
- Fierce Medtech's 2022 Fierce 15
- Illumina, Carl Icahn trade jabs amid looming proxy fight over $8B Grail buy
- Biogen, Novartis deliver one-two punch to Sangamo, walking away from deals in quick succession
- AbbVie's blockbuster-to-be Parkinson's combo hits a wall as FDA questions delivery pump
- Gilead's Yescarta puts pressure on BMS' Breyanzi with overall survival win in large B-cell lymphoma
- Selecta, Sobi rout gout in pair of phase 3 trials that could challenge Horizon
- Sanofi answers the call, joining Eli Lilly, Novo Nordisk in cutting insulin prices
- California invests $50M to partner with Civica Rx on insulin manufacturing
The Top Line is produced by senior podcast producer Teresa Carey and managing editor Querida Anderson. The sound engineer is Caleb Hodgson. The stories are by all our “Fierce” journalists. Like and subscribe wherever you listen to your podcasts.
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Is it all bad news in the bear market? Not necessarily.
After a tumultuous couple of years, many biotechs are looking for signs of improvement in 2023. After all, the biotech sector felt the market pain acutely, particularly over the last 18 months: 2022 marked the longest period of net negative performance for biotech stocks, with the SPDR S&P Biotech ETF XBI extending net losses over a 70-week period.
But things are looking up: the XBI was 7% up in January of this year, and investor sentiment seems to be improving.
Biotechs can look forward to some upward momentum if they take the right strategic steps now. In this podcast, Sara Michelmore and Karen Sharma from MacDougall Advisors share what biotechs can do to position themselves for this market swing.
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The sudden failure of Silicon Valley Bank sent shock waves across global markets. Fierce Biotech Senior Editor Annalee Armstrong talked with Kiah Haslett, managing editor of the publication Bank Director, about how SVB’s failure came to be and what to expect next.
Armstrong and Fierce staff writer Max Bayer chat about how the biotech sector reacted given that SVB served almost half of all venture-backed technology and life sciences companies. They reflect on what surprised them as journalists covering the SVB news. Plus, in this episode, we cover Pfizer's blockbuster Seagen buyout, an expanded antibody-drug conjugate collaboration and more of this week's top headlines.
To learn more about the topics in this episode:
- UPDATE: SVB failure triggers shock waves across biotech industry
- UK biopharma body praises bank for keeping doors open at life science startups by rescuing SVB UK
- Insulet tapped to replace SVB on S&P 500 index after bank collapse
- Biden says America's 'banking system is safe' after regulators back up all SVB deposits
- With $43B buyout, Pfizer sees cancer specialist Seagen as a 'goose' laying 'golden eggs'
- Synaffix, MacroGenics crack open ADC pact, tacking on $2.2B, 4 more programs
- Novo Nordisk follows Eli Lilly's lead, slashing insulin prices in the US
- Lilly's 10-year bet on treating Alzheimer's before symptoms start ends in failure
- PerkinElmer completes $2.45B spinoff to create new diagnostics, life sciences company
- FDA oncology chief aims to open up accelerated approval for earlier cancer treatment under 'Project FrontRunner'
- Podnosis, a Fierce Healthcare podcast
The Top Line is produced by senior multimedia producer Teresa Carey and managing editor Querida Anderson with editor-in-chief Ayla Ellison and senior editors Annalee Armstrong, Ben Adams, Conor Hale and Eric Sagonowsky. The sound engineer is Caleb Hodgson. The stories are by all our “Fierce” journalists. Like and subscribe wherever you listen to your podcasts.
See omnystudio.com/listener for privacy information.
Some expect the next few years will be an overall down period for pharma growth. So, Fierce’s Kevin Dunleavy invited Harietta Eleftherochorinou, Ph.D., of IQVIA to "The Top Line" to discuss why pharma needs to employ artificial intelligence and machine learning tools to stay ahead of the curve.
To learn more about the topics in this episode:
- 2023 forecast: An 'inflection point' for biopharma, fueled by a flood of AI and machine learning products
- Covis finally pulls preterm birth drug Makena after 12-year accelerated approval odyssey
- FDA sounds out de novo clearance for neuromodulation device to treat tinnitus
- FDA widens Lilly's Verzenio breast cancer reach, removes test and menopausal status demands
- Sarissa's overhaul of Amarin's board is complete with resignation of 7 holdover members
- AbbVie CEO Gonzalez scored $26M in 2022 pay as cash cow Humira neared patent cliff
- FDA delays BioMarin's gene therapy approval decision by 3 months
The Top Line is produced by senior multimedia producer Teresa Carey and managing editor Querida Anderson with editor-in-chief Ayla Ellison and senior editors Annalee Armstrong, Ben Adams, Conor Hale and Eric Sagonowsky. The sound engineer is Caleb Hodgson. The stories are by all our “Fierce” journalists. Like and subscribe wherever you listen to your podcasts.
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M&A plummeted in 2022 compared to the previous year. But some medtech companies were still able to pull off multibillion-dollar megadeals. We tracked it all on Fierce Medtech’s list of the 10 biggest M&A moves in 2022. In this episode, we discuss some high points from the roundup.
To learn more about topics in this episode:
- The top 10 medtech M&A deals of 2022
- Acquisitive Pfizer to strike again? Seagen back in M&A talks after Merck walked away: WSJ
- Eli Lilly slashes insulin prices by 70%, caps out-of-pocket costs in major access overhaul
- FDA hands first emergency authorization to over-the-counter test for both COVID and flu
- Sanofi, poised to rival Roche in hemophilia, nabs FDA approval for Altuviiio
- BioCryst hits another hurdle, delays trial for its one remaining clinical candidate
The Top Line is produced by senior multimedia producer Teresa Carey and managing editor Querida Anderson with editor-in-chief Ayla Ellison and senior editors Annalee Armstrong, Ben Adams, Conor Hale and Eric Sagonowsky. The sound engineer is Caleb Hodgson. The stories are by all our “Fierce” journalists. Like and subscribe wherever you listen to your podcasts.
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In October 2022, the Society for Immunotherapy of Cancer released a checklist for running phase 3 cancer immunotherapy combination studies. SITC's aim with these guidelines is to maximize the value of these trials. In this episode, Fierce Pharma staff writer Angus Liu discusses the checklist with Dr. Michael Atkins, the first author.
To learn more about topics in this episode:
- Moderna checks a few boxes in phase 3 mRNA flu shot trial, but misses on B strains and safety
- BD issues cybersecurity alert for hacking risk found in Alaris infusion pump software
- Apellis wins FDA approval for first geographic atrophy drug
- With FDA approval for Filspari, Travere turns Bristol Myers castoff into unique drug for rare kidney disease
The Top Line is produced by senior multimedia producer Teresa Carey and managing editor Querida Anderson with editor-in-chief Ayla Ellison and senior editors Annalee Armstrong, Ben Adams, Conor Hale and Eric Sagonowsky. The sound engineer is Caleb Hodgson. The stories are by all our “Fierce” journalists. Like and subscribe wherever you listen to your podcasts.
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Last August, Moderna filed a lawsuit against Pfizer and its COVID-19 vaccine partner, BioNTech. Moderna claims that the partners copied its mRNA technology and infringed its vaccine patents. Pfizer wasn’t going to sit back and take that. In September, the pharma giant dismissed the claims and accused Moderna of trying to rewrite the pandemic story to place itself in the “single, starring role,” the company’s attorneys wrote in a scathing countersuit.
Kevin Noonan, Ph.D., is an intellectual property lawyer. He spoke with Fierce Pharma staff writer Zoey Becker to discuss what is likely to be the most significant patent fight from the pandemic era.
To learn more about topics in this episode:
- Clash of the titans: Moderna sues Pfizer, BioNTech for mRNA patent infringement
- Pfizer, BioNTech strike back at Moderna with mRNA vaccine patent lawsuit
- Moderna won't enforce COVID-19 vaccine patents during pandemic
- Pfizer CEO's texts with European Commission chief trigger new NYT lawsuit
- NuVasive, Globus Medical ink $3.1B orthopedic device merger, sending investors scrambling
- Big Pharma divided? Pfizer, AZ, Lilly and more support Sanofi in high-profile Amgen patent fight
- GSK nixes next-gen COVID-19 antibody collaboration, leaving Vir to fly solo, seek new partners
- Call for nominations: The most influential people in biopharma in 2023
The Top Line is produced by senior multimedia producer Teresa Carey and managing editor Querida Anderson with editor-in-chief Ayla Ellison and senior editors Annalee Armstrong, Ben Adams, Conor Hale and Eric Sagonowsky. The sound engineer is Caleb Hodgson. The stories are by all our “Fierce” journalists. Like and subscribe wherever you listen to your podcasts.
See omnystudio.com/listener for privacy information.
2022’s slate of life sciences M&A deals didn’t meet expectations. But the year still featured tens of billions of dollars worth of biopharma acquisitions. Querida Anderson and Eric Sagonowsky discuss the top deals of the year.
Also on the show, Kevin Dunleavy and Fraiser Kansteiner reflect on last year’s largest buyout—Amgen's $28 billion deal for Horizon Therapeutics. They explore what it potentially means for the buyer's market this year. Plus, this week's top headlines and Max Bayer's and Kansteiner's scoop on Johnson & Johnson's R&D overhaul and layoff plans.
To learn more about topics in this episode:
- The top 10 biopharma M&A deals of 2022
- Buyout on Horizon: Amgen floats $28B offer for rare disease drug maker as Sanofi exits bidding war
- J&J's pharma group quietly works through global overhaul, with layoffs expected to reach multiple countries
- Gilead's Trodelvy snags vital breast cancer nod. But AZ, Daiichi's Enhertu casts long shadow
- Vertex pricing under fire—again—as activists press 4 governments for Trikafta generics
- Roche races to regulators after matching AstraZeneca's rare disease blockbuster in phase 3
- Call for nominations: The most influential people in biopharma in 2023
The Top Line is produced by senior multimedia producer Teresa Carey and managing editor Querida Anderson with editor-in-chief Ayla Ellison and senior editors Annalee Armstrong, Ben Adams, Conor Hale and Eric Sagonowsky. The sound engineer is Caleb Hodgson. The stories are by all our “Fierce” journalists. Like and subscribe wherever you listen to your podcasts.
See omnystudio.com/listener for privacy information.
After a complicated 2022, the new year offers a course correction for the obesity market. We'll hear from Fierce's Fraiser Kansteiner and Querida Anderson on the numerous opportunities ahead in the obesity market.
Also on the show, Fierce's Kevin Dunleavy and Eric Sagonowsky reflect on the the 37 new drugs approved in 2022. Plus, this week's headlines.
To learn more about topics in this episode:
- 2023 forecast: With Novo's Wegovy on a supply rebound, 2023 offers course correction and obesity showdown with Lilly
- Novo Nordisk's semaglutide set to tackle obesity with hotly-anticipated FDA green light
- Lilly's tirzepatide slides into FDA fast lane for obesity, turning up heat on Novo Nordisk's Wegovy
- 2022 drug approvals: After Aduhelm fiasco, FDA endorsements drop to 37
- Time to shine, biosims: Amgen's Amjevita readies long-awaited assault on AbbVie's Humira
- Amgen's Humira biosimilar Amjevita hits the market with 2 different list prices
- In mysterious FDA approval, Pfizer quietly wins Ibrance breast cancer expansion
- Pfizer warns Comirnaty sales will plummet by nearly two-thirds in 2023. And Paxlovid won't fare much better
- Philips cuts another 6,000 jobs as CPAP recall, supply chain snags send 2022 sales down 3%
- Researchers predict Alzheimer's progression 3.5 years early with unique blood test
The Top Line is produced by senior multimedia producer Teresa Carey and managing editor Querida Anderson with editor-in-chief Ayla Ellison and senior editors Annalee Armstrong, Ben Adams, Conor Hale and Eric Sagonowsky. The sound engineer is Caleb Hodgson. The stories are by all our “Fierce” journalists. Like and subscribe wherever you listen to your podcasts.
See omnystudio.com/listener for privacy information.
Just last year, congress passed the Inflation Reduction Act. The law contains several drug pricing measures hated by the pharmaceutical industry, including restrictions to price increases and Medicare negotiations. Eric Sagnowsky talked with Stacie Dusetzina, a professor at Vanderbilt University's Department of Health Policy, about what we can expect.
Also on the show, Fierce's Analee Armstrong and Gabrielle Mason reflect on the biotech industry last year and our expectation for 2023—plus, this week's headlines.
To learn more about topics in this episode:
- 2023 forecast: Despite Biden's drug pricing win, the biopharma industry is not 'anywhere near done with this conversation'
- 2023 forecast: Biotech plummeted from 'the highest of highs' in 2022. Will the sun shine again next year?
- Fierce Biotech Fundraising Tracker: Enlaza launches with $61M; Enveda brings in $68M
- Fierce Biotech Layoff Tracker: Layoffs strike 119 companies in 2022
- Theranos' Elizabeth Holmes labeled a 'flight risk' as she asks to delay prison sentence during appeal
- Eli Lilly shut out of Alzheimer's fast lane with FDA rejection for donanemab
- Health group lambasts CBS ‘60 Minutes’ segment for overt promotion of Novo Nordisk’s obesity med Wegovy
- Eli Lilly to pour $450M more into diabetes drug plant in North Carolina, add 100 jobs
- Frosty funding forecast forces Finch to stop phase 3 trial, lay off 95% of staff and seek buyers for assets
The Top Line is produced by senior multimedia producer Teresa Carey and managing editor Querida Anderson with editor-in-chief Ayla Ellison and senior editors Annalee Armstrong, Ben Adams, Conor Hale and Eric Sagonowsky. The sound engineer is Caleb Hodgson. The stories are by all our “Fierce” journalists. Like and subscribe wherever you listen to your podcasts.
See omnystudio.com/listener for privacy information.
Fierce’s JPM Week event was packed full of informative panels, executive interviews and fireside chats. So for today’s episode, we’ve pulled out a couple of snippets to take you inside the gathering.
First up, listen in on Fraiser Kansteiner’s lively panel discussion on how companies will keep their bottom lines strong while navigating the drug pricing policies that the Biden administration rolled out just last year. You will also hear from Zoey Becker’s interview with Bayer’s Christine Roth. As head of the oncology strategic business unit, Roth talks about the plans to establish Bayer as a strong competitor in the cancer space.
To learn more about topics in this episode:
- 2023 forecast: Despite Biden's drug pricing win, the biopharma industry is not 'anywhere near done with this conversation'
- To bolster IRA, lawmaker calls for new action to scrutinize cancer drug launch prices
- Pfizer, GSK, AbbVie and many more celebrate New Year with price hikes: report
- JPM23: Bayer hikes sales targets for Kerendia, Nubeqa to $3B each
- Look out, Pfizer. With new approval, Bayer's Nubeqa is set to challenge Xtandi's prostate cancer crown
- Bayer's blockbuster hopeful Nubeqa debuts in later-stage prostate cancer in UK under early access program
- Bayer poaches GlaxoSmithKline exec to lead expanding oncology business—including a blockbuster hopeful
- Fierce JPM Week
The Top Line is produced by senior multimedia producer Teresa Carey and managing editor Querida Anderson with editor-in-chief Ayla Ellison and senior editors Annalee Armstrong, Ben Adams, Conor Hale and Eric Sagonowsky. The sound engineer is Caleb Hodgson. The stories are by all our “Fierce” journalists. Like and subscribe wherever you listen to your podcasts.
See omnystudio.com/listener for privacy information.
The FDA is making some changes in the accelerated approval process. In this episode, we’ll discuss the recent changes with the FDA’s regulation of cancer drugs and how these shifts will impact the biopharma industry.
Also in this episode, we cover the week's biggest headlines from the annual J.P. Morgan Healthcare conference.
To learn more about topics in this episode:
- Fierce JPM Week
- Podnosis: The Pulse of the Healthcare Industry
- FDA wants confirmatory trials to be underway before granting accelerated cancer nods, Pazdur says
- Capitalizing on share price crash, AstraZeneca inks $1.8B CinCor takeover for blood pressure drug
- JPM23: Chiesi gets jump-start on JPM buzz with $1.48B Amryt buyout
- JPM23: Ipsen scoops up liver disease specialist Albireo for $952M
- Editas rewrites its own code after tough 2022, sending staff packing and editing down programs
- JPM23: Editas touts skinnier pipeline after major shake-up to ride out 'unfriendly' markets
- With Leqembi approval in Alzheimer's disease, Eisai and Biogen plot 'meticulous' launch
- AstraZeneca's first-in-class rescue inhaler Airsupra wins FDA nod—but only for adult use
- Baxter bids adieu to $5B kidney care division with spinout plan
"The Top Line" is produced by senior multimedia producer Teresa Carey with managing editor Querida Anderson and senior editors Annalee Armstrong, Ben Adams, Conor Hale and Eric Sagonowsky. The sound engineer is Caleb Hodgson. The stories are by all our “Fierce” journalists. Like and subscribe wherever you listen to your podcasts.
See omnystudio.com/listener for privacy information.
There were a lot of moments in 2022 that left us scratching our heads. In this episode, we’ll recap biotech’s top blunders, boondoggles, gaffes and missteps in our "Rotten Tomatoes" report—plus, we highlight two ripened tomatoes that gave us hope.
Also in this episode, we cover the week's biggest headlines including drug approvals late in the last stretch of 2022, Moderna's first buy and why Biogen and the FDA are in hot water.
To learn more about topics in this episode:
- Fierce Biotech's Rotten Tomatoes of 2022
- Roche gets FDA nod for Lunsumio, offering convenient option to gene therapies in follicular lymphoma
- After overcoming vial issue, Gilead wins FDA approval for long-acting HIV injectable Sunlenca
- After FDA's Ukoniq pull, TG Therapeutics wins commercial mulligan with Briumvi to enter crowded MS arena
- Biogen, FDA's inappropriate Aduhelm coordination detailed in blistering congressional report
- Moderna makes its first-ever acquisition, buying Japanese DNA manufacturer OriCiro for $85M
- Moderna CEO says mpox vaccine is 'fantastic.' It may never see the market
- GE HealthCare completes spinout into 'more focused, more agile' standalone company
- We're looking for the fiercest companies for Fierce Medtech's 2022 Fierce 15
- Fierce JPM Week
"The Top Line" is produced by senior multimedia producer Teresa Carey with managing editor Querida Anderson and senior editors Annalee Armstrong, Ben Adams, Conor Hale and Eric Sagonowsky. The sound engineer is Caleb Hodgson. The stories are by all our “Fierce” journalists. Like and subscribe wherever you listen to your podcasts.
See omnystudio.com/listener for privacy information.
We totaled the salaries, stock options and bonuses awarded to various medtech CEOs to figure out who the highest paid chiefs were. And our top 10 list saw a few ups and downs over the past year. We'll hear from Connor Hale and Andrea Park as they discuss medtech's highest paid CEOs.
Also in this episode, we cover the week's biggest headlines including Theranos' COO's jail sentence, highlights from the American Society of Hematology annual meeting, and an update on the Horizon Therapudics bidding war.
To learn more about topics in this episode:
- Fierce JPM Week
- The top 10 highest-paid medtech CEOs
- Fierce Biotech's ASH 2022 Coverage
- Fierce Pharma's ASH 2022 Coverage
- Theranos' Sunny Balwani lands 13-year fraud sentence after ex-partner Elizabeth Holmes gets 11 years
- Watch out, Amgen. Mirati kicks off KRAS showdown with FDA approval for Krazati
- FDA advisers nix Cytokinetics' heart failure med, rejecting argument for subgroup use
- Buyout on Horizon: Amgen floats $28B offer for rare disease drug maker as Sanofi exits bidding war
- Sanofi started—and lost—$28B bidding war for Horizon. Is the company's M&A appetite still rumbling?
- AstraZeneca, Biogen, Daiichi, Lundbeck, UCB all hit with drug marketing breaches, but highest censure reserved for Novo Nordisk
"The Top Line" is produced by senior multimedia producer Teresa Carey with managing editor Querida Anderson and senior editors Annalee Armstrong, Ben Adams, Conor Hale and Eric Sagonowsky. The sound engineer is Caleb Hodgson. The stories are by all our “Fierce” journalists. Like and subscribe wherever you listen to your podcasts.
See omnystudio.com/listener for privacy information.
Last week, senior editor Annalee Armstrong and staff writer Gabrielle Mason covered the Clinical Trials on Alzheimer’s Disease conference. We'll hear from them as they discuss the latest news and what surprised them.
Also in this episode, we cover the week's biggest headlines including an investigation into Neuralink, Google’s DeepMind and why things aren't working out for PI3Ks.
To learn more about topics in this episode:
- Eisai, Biogen rocked by 2nd lecanemab death report ahead of Alzheimer's data reveal
- Facing a familiar side effect problem, Eisai makes the case for its next Alzheimer's drug after patient deaths
- Roche thins Alzheimer's program after phase 3 failure, may seek 'external partnerships'
- A winner is crowned in head-to-head Alzheimer's battle between Biogen's Aduhelm and Lilly
- Neuralink under federal investigation for animal testing practices: Reuters
- Elon Musk claims Neuralink is 6 months from implanting brain-computer interfaces in humans—and, someday, he'll be one of them
- 'Troubling' study finds Google's kidney disease-predicting AI performs worse in women—and may not have a quick fix
- In fresh blow to floundering PI3K space, FDA feedback drives MEI, Kyowa to halt blood cancer program
- Rigel scores green light in AML just 4 months after buying asset from Forma
- UPDATED: J&J bows out of Horizon bid as Amgen and Sanofi eye cash plays for rare disease drugmaker
- Pfizer plots €1.2B investment—and up to 500 new jobs—at Irish manufacturing plant
- Fierce JPM Week
"The Top Line" is produced by senior multimedia producer Teresa Carey with managing editor Querida Anderson and senior editors Annalee Armstrong, Ben Adams, Conor Hale and Eric Sagonowsky. The sound engineer is Caleb Hodgson. The stories are by all our “Fierce” journalists. Like and subscribe wherever you listen to your podcasts.
See omnystudio.com/listener for privacy information.
Biogen recently named Christopher Viehbacher its new CEO, ending a monthslong search to replace Michel Vounatsos. Fraiser Kansteiner and Kevin Dunleavy talk about the current state of the company and recent investor reactions to the new hire. Plus, they discuss a string of other biopharma CEO appointments.
And, in this episode, we cover the week's news including what Albert Bourla, Ph.D., said that has him in hot water along with a $3.5 million drug, and we tease a possible major acquisition.
To learn more about topics in this episode:
- Biogen's incoming CEO Viehbacher gets mixed reviews—and lots of advice—in investor survey
- Sporting a $3.5M price tag, CSL and uniQure's hemophilia B gene therapy crosses FDA finish line
- Eisai, Biogen rocked by 2nd lecanemab death report ahead of Alzheimer's data reveal
- Facing a familiar side effect problem, Eisai makes the case for its next Alzheimer's drug after patient deaths
- Amgen, J&J and Sanofi size up Horizon as Big Pharma renews interest in rare disease M&A
- Pfizer CEO Bourla stung by UK's pharma marketing regulator over kids' COVID vax claims: report
- GE Healthcare unveils AI program bundle for simplified MRI scans
- Philips unveils AI-powered platform to improve diagnoses from imaging scans
"The Top Line" is produced by senior multimedia producer Teresa Carey with managing editor Querida Anderson and senior editors Annalee Armstrong, Ben Adams, Conor Hale and Eric Sagonowsky. The sound engineer is Caleb Hodgson. The stories are by all our “Fierce” journalists. Like and subscribe wherever you listen to your podcasts.
See omnystudio.com/listener for privacy information.
Learn how Slope’s eClinical Supply Chain Management platform provides robust technology to the clinical trial space, covering all areas of supply management without losing sight of the chain of custody.
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This week on "The Top Line," we discuss 2022’s Fiercest Women in Life Science honorees. Each year, we spotlight women who are leading the way in life sciences—women who stand out as leaders, innovators and mentors. We’ll hear from Andrea Park and Querida Anderson on what it took to make the cut for this year's class of fiercest women in life sciences. Plus, this week's headlines.
To learn more about topics in this episode:
- 2022's Fiercest Women in Life Sciences
- Eli Lilly issues rare apology as fake Twitter Blue account proclaims free insulin for all
- Eli Lilly pulls Twitter ads after blue check fallout: report
- Roche's anti-amyloid antibody gantenerumab fails phase 3 in major blow to Alzheimer's ambitions
- NFL expands head injury research project using impact-tracking mouthguards, as concussion protocols come under fire
- Mayo Clinic launches digital referee for spotting potential bias in healthcare AI programs
- Four decades in, ImmunoGen gets landmark green light in advanced ovarian cancer
- Sanofi, GSK crash the COVID-19 vaccine party late with a world-first nod for their next-gen booster
"The Top Line" is produced by senior multimedia producer Teresa Carey with managing editor Querida Anderson and senior editors Annalee Armstrong, Ben Adams, Conor Hale and Eric Sagonowsky. The sound engineer is Caleb Hodgson. The stories are by all our “Fierce” journalists. Like and subscribe wherever you listen to your podcasts.
See omnystudio.com/listener for privacy information.
This week on "The Top Line," we'll share highlights from the Cell & Gene Therapy Forum. Lack of access and multimillion-dollar costs have stirred debate over the appropriate price of potentially lifesaving cell and gene therapies. Fierce’s Max Bayer spoke with a panel of stakeholders at the forum. They discussed the state of play for cell and gene therapies and how they can become a genuine game changer for the many, not the few. We also talk with executives from Poseida Therapeutics and AviadoBio.
To learn more about topics in this episode:
- Zolgensma for dementia? AviadoBio gains orphan tag for one-dose gene therapy
- Poseida taps former Novartis VP as president of gene therapy
- Fierce Biotech Summit: Disruptive gene technology is here—and society seems willing to pay for it
- Fierce Biotech Cell & Gene Forum
"The Top Line" is produced by senior multimedia producer Teresa Carey with managing editor Querida Anderson and senior editors Annalee Armstrong, Ben Adams, Conor Hale and Eric Sagonowsky. The sound engineer is Caleb Hodgson. The stories are by all our “Fierce” journalists. Like and subscribe wherever you listen to your podcasts.
See omnystudio.com/listener for privacy information.
After more than a year of respirator recalls, it’s probably no surprise that Philips reported lower-than-expected revenues for the third quarter of this year. But that announcement also came with the revelation that the company is now laying off 4,000 workers and planning for even more restructuring. Fierce Medtech's Andrea Park discusses this latest news and digs into the long line of problems that led to this decision.
Philips' downward slide started last June, with the recall of CPAP and BiPAP machines used to treat sleep apnea. As of this July, the FDA tallied 168 related deaths, and as of mid-October there were at least 342 pending class action cases against the company.
- Philips cuts 4,000 jobs, with more restructuring on the way, amid slipping sales and rising costs
- With FDA decision penciled in for May, GSK powers ahead in RSV race with Pfizer
- Johnson & Johnson doles out $16.6B to snatch up miniaturized heart pump maker Abiomed
- Thermo Fisher ties up $2.6B deal for cancer diagnostics maker The Binding Site
- Alkermes joins Bristol Myers in IL-2 exit with oncology business spinoff
- Pfizer boosts COVID vaccine projection to $34B on the back of strong Comirnaty haul
See omnystudio.com/listener for privacy information.
It’s earnings season again. Biogen offered a look at its second foray into Alzheimer’s disease during its investor call, but listeners were still left dubious. All eyes—and ears—are on whether its lecanemab partnership with Eisai can outperform the ill-fated Aduhelm. In this episode, we chat about what went down during the earnings presentation, including rumors of a shaky relationship between the two drugmakers.
We also explore AstraZeneca finally claiming an FDA approval for its long-troubled cancer immunotherapy Imjudo. The CTLA-4 drug has failed more than a few trials among different tumors over the years, and, now, it will enter a crowded and highly competitive liver cancer market.
- UPDATED: Biogen insists Eisai relationship 'solid' as questions remain over lecanemab commercialization
- Despite Aduhelm cost cuts, Biogen still has Alzheimer's manufacturing firepower on deck, CFO says
- AstraZeneca's Imjudo finally snags first approval—only in an ever-crowded liver cancer field
- AIDS advocacy group hits out at 'Greediad' Gilead for drug pricing hikes
- J&J's BCMA bispecific Tecvayli wins FDA approval in multiple myeloma—but as a late-line therapy
- Medtronic to spin out respiratory, patient monitoring divisions amid flagging ventilator sales
- Sumitomo nets Myovant in $2.9B buyout, adding IVF asset to pipeline
"The Top Line" is produced by senior multimedia producer Teresa Carey with managing editor Querida Anderson and senior editors Annalee Armstrong, Ben Adams, Conor Hale and Eric Sagonowsky. The sound engineer is Caleb Hodgson. The stories are by all our “Fierce” journalists. Like and subscribe wherever you listen to your podcasts.
See omnystudio.com/listener for privacy information.
We just released a special report on the top 10 vaccine companies. We haven’t published this report since 2017, when we only profiled five manufacturers. But five years and one COVID pandemic later, that order has been completely shuffled with many new faces. It’s clear that the vaccine industry is changing fast. In today's episode we'll discuss those global rankings, plus this week's headlines.
To learn more about topics in this episode:
- The top 10 vaccine companies worldwide
- Pfizer takes Vyndaqel copay fight to Supreme Court, decrying 'staggeringly overbroad' anti-kickback rule
- Atara on verge of landmark approval for first allogeneic T-cell therapy
- J&J sets sights on $60B in pharma sales by 2025, targets 8 brands to deliver growth
- As FDA rule takes effect, Lucid Hearing launches over-the-counter line of hearing aids
The Top Line is produced by senior multimedia producer Teresa Carey with managing editor Querida Anderson and senior editors Annalee Armstrong, Ben Adams, Conor Hale and Eric Sagonowsky. The sound engineer is Caleb Hodgson. The stories are by all our “Fierce” journalists. Like and subscribe wherever you listen to your podcasts.
See omnystudio.com/listener for privacy information.
The world’s most productive biopharmas have gone through some major changes in the past five years. In Fierce Pharma’s latest analysis, BioNTech and Moderna beat their biopharma peers with the highest 2021 revenues per employee. The 2021 cohort as a whole showed improved productivity over 2016, although several companies experienced declines. In this episode, we'll discuss our special report on the most productive pharmas.
Also under discussion is Biogen's tumultuous year, which was spurred by its disastrous Alzheimer’s disease drug launch. Now Biogen is reportedly considering Theravance co-founder Mathai Mammen , M.D., Ph.D>, as its new CEO. The company supposedly wants to emphasize scientific know-how in choosing its next leader.
To learn more about topics in this episode:
- The top 10 most productive biopharma companies
- J&J research vet Mathai Mammen a top contender in Biogen's hunt for a new CEO: Stat
- Merck nails phase 3 sotatercept win, making good on its $11.5B Acceleron buy
- AstraZeneca's COVID-19 nasal vaccine spray comes up a bust in small study
- Fitbit embeds health, activity data into Pretaa's substance abuse recovery app
- Merck & Co., in busy morning, taps Moderna's therapeutic cancer vaccine, Royalty in schizophrenia deal
- Orthofix, SeaSpine to combine into $700M orthopedics player in merger of equals
The Top Line is produced by senior multimedia producer Teresa Carey with managing editor Querida Anderson and senior editors Annalee Armstrong, Ben Adams, Conor Hale and Eric Sagonowsky. The sound engineer is Caleb Hodgson. The stories are by all our “Fierce” journalists. Like and subscribe wherever you listen to your podcasts.
See omnystudio.com/listener for privacy information.
Eisai and Biogen's Alzheimer’s disease drug lecanemab did surprisingly well in a phase 3 trial. The results support the idea that an anti-amyloid drug like lecanemab could be a way to treat Alzheimer’s—a hypothesis that has been under fire since Biogen's debacle with its approved anti-amyloid med, Aduhelm. And, while lecanemab's approvability isn't being debated—unlike the case with Aduhelm after its phase 3 program read out—commercial reimbursement could still be a challenge for the Eisai drug.
We'll also talk about football, or at least Pfizer's COVID vaccine ad campaign that kicked off during the NFL season. The company's marketing strategy over the last almost two years has changed over time and with various approvals. Recently, Pfizer ramped up its campaign with branded advertising for shots in teens, but its NFL season push is focused on its new, tweaked booster vaccine and takes a more subtle approach but with big money behind it.
To learn more about topics in this episode:
- It's a hit: Eisai springs 'major surprise' with phase 3 win for Biogen-partnered Alzheimer's drug
- Eisai and Biogen's phase 3 Alzheimer's win puts amyloid back in the driver's seat, for now
- Editor's Corner: Eisai and Biogen need to meet CMS halfway after lecanemab's Alzheimer's clinical trial win
- NFL season sees Pfizer kick off major Comirnaty COVID vaccine ad offensive for teens, boosters
- Pfizer offers a soft sell with a strong message on vaccines in first COVID ad
- The inside story behind Pfizer and BioNTech's new vaccine brand name, Comirnaty
- Sign of the times? US stocks up on Amgen's radiation sickness drug Nplate
- Capacity to spare: US has manufacturing firepower to crank out more essential medicines, researchers say
- Illumina pitches $200 genomes with new line of DNA sequencers
- Novo Nordisk ready to submit once-weekly insulin to FDA after scoring final phase 3 win
- Ocaliva fails NASH trial just as Intercept charts path toward FDA application
The Top Line is produced by senior multimedia producer Teresa Carey with managing editor Querida Anderson and senior editors Annalee Armstrong, Ben Adams, Conor Hale and Eric Sagonowsky. The sound engineer is Caleb Hodgson. The stories are by all our “Fierce” journalists. Like and subscribe wherever you listen to your podcasts.
See omnystudio.com/listener for privacy information.
Every year, our Fierce Biotech team evaluates hundreds of early-stage companies from around the world. Only the most promising are selected for our annual list of Fierce 15 honorees. That list is based on a variety of factors like the strength of the company’s technology, partnerships, venture backers and a competitive market position. This year’s 15 honorees were recognized at the Fierce Biotech Summit. In this episode, we'll hear directly from them about their company’s work, what makes it unique, and what drives them.
We'll also take you to the Fierce Biotech Summit. It happened in Boston on September 19 and 20, and covered drug development from the earliest stage of research to FDA approval. So if you missed the summit, this episode covers some event highlights including a panel moderated by Fierce Pharma senior staff writer Angus Liu on the future of gene editing and a session moderated by managing editor Querida Anderson on battling biotech's bear market.
To learn more about topics in this episode:
- Special Report: Fierce Biotech's 2022 Fierce 15
- The Fierce Biotech Summit: Where Biotech Innovation Happens
- Fierce Biotech Summit: As the biotech market teases turning a corner, stakeholders say we're in a 'new normal'
- Servier severs CAR-T collab with Allogene, handing back rights outside the US to 3 candidates
- Months after exiting clinical hold, Pfizer readies to resume dosing in phase 3 gene therapy trial
- ESMO: BioNTech's CAR-T response rate falls in fresh cut of early-phase data
The Top Line is produced by senior multimedia producer Teresa Carey with managing editor Querida Anderson and senior editors Annalee Armstrong, Ben Adams, Conor Hale and Eric Sagonowsky. The sound engineer is Caleb Hodgson. The stories are by all our “Fierce” journalists. Like and subscribe wherever you listen to your podcasts.
See omnystudio.com/listener for privacy information.
Two Big Pharma companies, GSK and Takeda, made moves this week to bolster their environmental sustainability efforts. GSK is focusing on its supply chain and Takeda on its electrical sources in the U.S. In GSK’s case, the development is part of a larger trend of companies focusing on emissions from outside of their direct operations. Fierce's Fraiser Kansteiner and Eric Sagonowsky will discuss what we can expect on environmental sustainability at Big Pharmas.
To learn more about topics in this episode:
- GSK puts suppliers on the hook as it amps up sustainability crusade
- A $3M gene therapy: Bluebird bio breaks its own pricing record with FDA approval of Skysona
- Merck finally gets FDA nod to relaunch HIV trials, but drops preventive therapy plans
- FDA plans advisory committee meeting to discuss racial bias built into pulse oximeters
- Smartphone cameras could replace pulse oximeters to measure blood oxygen at home: study
- Rise of the machines: Novo Nordisk pledges $200M to create first quantum computer for life sciences
The Top Line is produced by senior multimedia producer Teresa Carey with managing editor Querida Anderson and senior editors Annalee Armstrong, Ben Adams, Conor Hale and Eric Sagonowsky. The sound engineer is Caleb Hodgson. The stories are by all our “Fierce” journalists. Like and subscribe wherever you listen to your podcasts.
See omnystudio.com/listener for privacy information.
Medical conferences often are a platform to showcase new clinical trophies. But that wasn't the case for Merck at this year’s European Society for Medical Oncology meeting. The Big Pharma presented a series of trial flops for its megablockbuster cancer immunotherapy, Keytruda. We'll discuss if the Merck checkpoint inhibitor has reached a bottleneck or if it was just bad luck.
Also under discussion is the monkeypox test Emergency Use Authorization. Because monkeypox continues to spread in the U.S. and worldwide, the FDA granted its first EUA for a diagnostic test. This regulatory path was also used for COVID-19 tests. But the FDA learned a few lessons from the pandemic and hopes the new guidelines will help avoid the problems seen then.
To learn more about topics in this episode:
- ESMO: AstraZeneca, Merck tout Lynparza's 'clinically meaningful' ovarian cancer survival edge but lose one in prostate cancer
- ESMO: Roche eyes untouched newly diagnosed lung cancer market for solo Tecentriq
- ESMO: Adding bempeg to Opdivo lowered response rate in Bristol Myers-Nektar failed cancer trial
- ESMO: GSK keeps the faith in anti-TIGIT plans; it's 'not always about being first'
- UPDATED ESMO: Amgen's Lumakras confirmatory lung cancer data leave door open for KRAS competitors
- ESMO: Gilead's Trodelvy makes surprise comeback with above-par breast cancer survival showing
- Here we go again: FDA opens up emergency authorizations to monkeypox tests
- Moderna sizes up private COVID vaccine market in US, where shots could cost $100 a pop
- Sony dives into nascent over-the-counter hearing aid market with WS Audiology partnership
- OTC birth control could be on the way from Perrigo, as FDA gathers expert panel
- Altimmune sees phase 1 success in tricky NASH indication with GLP-1 agonist
- Oramed phase 2 insulin drug data 'paint an exciting picture' in rocky NASH landscape
- Akero hits endpoints in midphase NASH trial, linking candidate to improvements in fibrosis
- BMS’ preferred drug in its $74B Celgene buy is set to pay dividends, winning its first FDA nod
The Top Line is produced by senior multimedia producer Teresa Carey with managing editor Querida Anderson and senior editors Annalee Armstrong, Ben Adams, Conor Hale and Eric Sagonowsky. The sound engineer is Caleb Hodgson. The stories are by all our “Fierce” journalists. Like and subscribe wherever you listen to your podcasts.
See omnystudio.com/listener for privacy information.
The FDA has given Sarepta Therapeutics the green light for its phase 2 Duchenne muscular dystrophy clinical trial after slapping the biotech with a clinical hold in June. The hold came after a grade 3 adverse event was reported in the midstage trial. Now, only a few months later, the agency has lifted the hold, and we'll discuss why there was a quick turnaround on the hold and what to expect next.
To learn more about topics in this episode:
- Sarepta picks up momentum as FDA lifts hold on phase 2 DMD trial
- As EU challenge intensifies, Illumina clocks a stateside win in FTC antitrust case over Grail buy
- EU blocks Illumina's yearslong quest for Grail
- Philips recalls 17M CPAP and BiPAP machine masks due to potential magnet interference
- GSK helps SpringWorks double payday from boosted combo deal as it also reels $225M in new funding
- BMS-backed Arsenal Bio pulls trigger on $220M series B, touting potential fleet of gene-edited cell therapies
- Amylyx's ALS drug faces tough FDA scrutiny ahead of 2nd advisory panel meeting
The Top Line is produced by senior multimedia producer Teresa Carey with managing editor Querida Anderson and senior editors Annalee Armstrong, Ben Adams, Conor Hale and Eric Sagonowsky. The sound engineer is Caleb Hodgson. The stories are by all our “Fierce” journalists. Like and subscribe wherever you listen to your podcasts.
See omnystudio.com/listener for privacy information.
In Alzheimer’s, three drug candidates capture most of the industry's attention these days, and for good reason. They’re all in late-stage development and have the likes of Biogen, Eisai, Genentech and Eli Lilly backing them. But in this week’s episode, we step away from the big three. The Alzheimer’s Association found that there are 143 drugs in the pipeline. If fully enrolled, these trials would involve 50,575 people and more than 3.8 million participant weeks. We’ll dive into these details and more tidbits from AA’s report.
And that’s not all. As we gear up to publish our annual Fierce 15 report honoring biotechs with the most exciting technologies, we’re also taking the time to look back at our 2012 class of Fierce 15. By now, several companies have fallen off the map, but many others were part of blockbuster deals or continue to plug away at their pipelines. We profile all of them, what they’ve been up to and what’s coming next.
To learn more about topics in this episode:
- Beyond headlines and amyloid, the Alzheimer's pipeline chugs along
- Where are they now? Tracking down 2012's Fierce 15
The Top Line is produced by senior multimedia producer Teresa Carey with managing editor Querida Anderson and senior editors Annalee Armstrong, Ben Adams, Conor Hale and Eric Sagonowsky. The sound engineer is Caleb Hodgson. The stories are by all our “Fierce” journalists. Like and subscribe wherever you listen to your podcasts.
See omnystudio.com/listener for privacy information.
Senior Editor Annalee Armstrong was doing a pretty routine interview with Genentech’s Greg Rippon when she heard what she says was a mea culpa. Genentech wasn't able to recruit the kind of diverse population that would truly reflect the predominance of Alzheimer’s in non-white communities. Annalee will discuss what she heard from Rippon about the lack of trial diversity and how Genentech hopes to get it right in the future.
How memorable are diabetes brands? According to a new report out by Phreesia, patients are too overloaded with names to remember. We'll discuss how pharma companies could change their marketing strategy.
To learn more about topics in this episode:
- Genentech didn't get it right on diversity for critical Graduate Alzheimer's program. They're trying again
- Diabetes brand awareness in the doldrums despite plowing big bucks into ad campaigns
- Abbott proclaims FDA approval of neurostimulator to treat pain in 6 areas at once
- After FDA rejection, Gilead's long-acting HIV med Sunlenca snags first global nod
- Third Harmonic, with an old Novartis drug in hand, braves frosty IPO waters in a quick-fire cash grab
- Alcon swoops on Aerie, striking $770M buyout to expand eye drug pipeline
- Ex-Novartis unit Alcon keeps eye med expansion rolling with $770M pact to snap up Aerie
- Alcon scopes out $475M acquisition of glaucoma stent maker Ivantis
- UPDATED: Teva won't reopen troubled California site, where 300-plus are losing their jobs
- We're looking for 2022's Fiercest Women in Life Sciences—closes this week
The Top Line is produced by senior multimedia producer Teresa Carey with managing editor Querida Anderson and senior editors Annalee Armstrong, Ben Adams, Conor Hale and Eric Sagonowsky. The sound engineer is Caleb Hodgson. The stories are by all our “Fierce” journalists. Like and subscribe wherever you listen to your podcasts.
See omnystudio.com/listener for privacy information.
Novartis has recorded two deaths after treatment with its gene therapy Zolgensma. The treatment is for spinal muscular atrophy. Two children in Russia and Kazakhstan died about five to six weeks after receiving Zolgensma. Both patients died of acute liver failure, a known side effect of Zolgensma. In today's episode, we will discuss these deaths and the gene therapy’s safety.
AstraZeneca may be a major oncology player, but the company has been noticeably absent in the first wave of CAR-T therapies. All that may be about to change. We chat with Dave Fredrickson, from the Big Pharma's oncology unit, about how the company is working on the next generation of these cancer therapies.
To learn more about the topics in this episode:
- 2 deaths after Novartis' Zolgensma put gene therapy's liver safety in the spotlight once again
- Late to the CAR-T game, AstraZeneca quietly works on its own off-the-shelf therapies
- UPDATED: Bluebird bio's $2.8M gene therapy Zynteglo wins FDA backing. Will its US launch take flight?
- Hear ye, hear ye: FDA finalizes OTC hearing aid rule to amp up access, drive down costs
- Sanofi scraps oral SERD strategy after 2nd failure in breast cancer
- Are SERDs dead? 'Good question,' says Sanofi R&D chief, after French pharma's late-stage pipeline takes a beating
- After billions in legal costs, Johnson & Johnson plans to halt talc sales worldwide
- AstraZeneca heads to court to contest former exec's move to crosstown rival GSK: report
- CPAP machine competitor ResMed nears $3.6B revenue in first year of Philips' ventilator recall
- Merck bets big on circular RNA, paying $150M and dangling $3.5B in biobucks to work with Orna
- AZ, Daiichi Sankyo's Enhertu breaks more ground, nabbing fast FDA nod in HER2-mutant lung cancer
- We're looking for 2022's Fiercest Women in Life Sciences
The Top Line is produced by senior multimedia producer Teresa Carey with managing editor Querida Anderson and senior editors Annalee Armstrong, Ben Adams, Conor Hale and Eric Sagonowsky. The sound engineer is Caleb Hodgson. The stories are by all our “Fierce” journalists. Like and subscribe wherever you listen to your podcasts.
See omnystudio.com/listener for privacy information.
Sunday, the U.S. Senate passed the landmark drug pricing bill. While the pharmaceutical industry favors the bill’s Medicare out-of-pocket cap for patients, the industry has also put up a major fight against Medicare pricing negotiations, in fact deeming them "price controls." The bill’s passage marked a loss for the industry, but analysts aren’t sure how much the legislation will actually cut drug prices.
Pfizer is riding high on its COVID-19 windfall. And with all that money in the bank, the Big Pharma has been busy scouring the biopharma landscape for new assets and companies to bring into its fold. The latest in its buying spree is a $5.4 billion acquisition of Global Blood Therapeutics and its marketed sickle cell disease drug.
To learn more about the topics in this episode:
- Lilly, AZ, AbbVie and J&J face big potential hit from Medicare pricing bill: analysts
- 'Litany of false promises': Pharma bemoans drug pricing bill as patient advocates celebrate
- VC firms, biotechs push back on drug pricing bill that would render small molecule drugs 'uninvestable'
- Pfizer, riding high on COVID windfall, strikes $5.4B buyout of Global Blood Therapeutics
- In historic FDA nod, AstraZeneca, Daiichi’s Enhertu snags ultrafast approval in broad HER2-low breast cancer use
- Struggling Novavax halves its sales forecast as COVID shot launch sputters
- Amid COVID vaccine demand slump, Moderna recorded $800M-plus in charges for unused inventory and more
- With COVID vaccine demand in free fall, BioNTech's revenue plummets nearly 40% in second quarter
- GSK bets $1.3B on Mersana’s preclinical ADC and chance to expand portfolio beyond Blenrep
- Merck is back in Alzheimer's saddle with $1B+ Cerevance pact, years after dropping the BACE
- BMS bites at GentiBio’s next-gen regulatory T cells, betting $1.9B on 3 programs
- In warranty program, Pfizer will refund up to $50K for patients who discontinue use of rare disease drug
- We're looking for 2022's Fiercest Women in Life Sciences
The Top Line is produced by senior multimedia producer Teresa Carey with managing editor Querida Anderson and senior editors Annalee Armstrong, Ben Adams, Conor Hale and Eric Sagonowsky. The sound engineer is Caleb Hodgson. The stories are by all our “Fierce” journalists. Like and subscribe wherever you listen to your podcasts.
See omnystudio.com/listener for privacy information.
It's earnings season—a time when publicly traded pharmas and biotechs tell their investors how they've performed over the previous quarter. But aside from drug sales figures, it’s a great opportunity to get a sense of how these companies' pipelines have changed. We'll dig into that, and even the stuff that companies are less keen to talk about.
Regeneron once boasted one of the top COVID-19 therapeutics in its antibody cocktail REGEN-COV. Now, the company is terminating four studies for the med across a range of patients and clinical stages. The move follows the FDA’s decision to pull the medication from the market in January, citing uncertain efficacy against the surging omicron variant. And Regeneron’s antibody combo isn’t alone. We'll discuss how early pandemic therapeutics have fallen by the wayside.
To learn more about the topics in this episode:
- AstraZeneca axes Moderna-partnered, phase 2 heart disease drug plus a Wee inhibitor
- BMS-Ambrx collab runs out of steam after FA relaxin med canned
- Takeda cuts ties to cancer drug landed in $120M Turnstone deal
- The NASH curse strikes again. Pfizer dumps early-stage asset for liver condition
- AstraZeneca axes Moderna-partnered, phase 2 heart disease drug plus a Wee inhibitor
- PerkinElmer to rebrand as life-science-focused supplier, sell off other businesses in $2.45B deal
- Merck's Keytruda, on a losing streak, fails in once FDA-rejected liver cancer use and prostate cancer—again
- Bristol Myers' Opdivo-Yervoy combo joins Roche on the postsurgery kidney cancer flop list
- Axcella misses primary endpoint in long COVID trial but plots path to market based on fatigue scores
- Bose abandons hearing aid plans, hands off direct-to-consumer tech to Lexie Hearing
- We're looking for 2022's Fiercest Women in Life Sciences
The Top Line is produced by senior multimedia producer Teresa Carey with editor-in-chief Tracy Staton, managing editor Querida Anderson and senior editors Annalee Armstrong, Ben Adams, Conor Hale and Eric Sagonowsky. The sound engineer is Caleb Hodgson. The stories are by all our “Fierce” journalists. Like and subscribe wherever you listen to your podcasts.
See omnystudio.com/listener for privacy information.
Last month, Fierce hosted an event to talk with experts across the industry about what's beyond the leading edge of biotech and pharma. This week's episode brings you discussion from four of the panel discussions. Our first panel focused on Alzheimer’s disease, where success is hard to come by. The panelists discussed the learnings that can come from past failures. We also had a panel about the industry’s environmental impact. As more companies are rolling out programs to cut carbon emissions, reduce waste and plug into alternative energy sources, we asked sustainability experts if pharma is doing enough and what more needs to be done.
You'll also hear from our panelists on cell and gene therapies and why pricing concerns still loom. Only a few such therapies have made it to market so far. But as more hit the scene, insurers and pharmaceutical companies need to think about how to pay for them to avoid sticker shock. Finally, the use of artificial intelligence (AI) methods in drug research and development is really starting to take off. Businesses are increasingly using AI tools to find drugs—and it is working faster and more efficiently. We'll explore AI's evolution in drug discovery.
To learn more about the topics in this episode:
- Fierce Next Gen: Despite another key trial failure, Alzheimer's therapy developers find reason for optimism
- Setting sights on suppliers: How biopharma is tackling the environment in its ESG commitments
- Fierce Next Gen: As gene therapies proliferate, pharma and payers look to avoid 'cost shocks'
- Fierce Next Gen: Biopharma begins to hand AI the keys to the research car
- Justice Department cracks down on $1.2B worth of lab testing, telehealth fraud schemes
The Top Line is produced by senior multimedia producer Teresa Carey with editor-in-chief Tracy Staton, managing editor Querida Anderson and senior editors Annalee Armstrong, Ben Adams, Conor Hale and Eric Sagonowsky. The sound engineer is Caleb Hodgson. The stories are by all our “Fierce” journalists. Like and subscribe wherever you listen to your podcasts.
See omnystudio.com/listener for privacy information.
If there’s been one theme that tells a story about biotech’s situation in 2023, it’s layoffs. The number of staff layoffs across the sector reached such a height that Fierce Biotech began keeping track in March with our Layoff Tracker. We'll discuss the surprising trend and what it might mean for the biotech industry.
And that's not all. Every year, Fierce puts together a special report ranking the top 10 companies by generic drug sales. We discuss those rankings and also the interesting things going on in that sector of the industry.
To learn more about the topics in this episode:
- Fierce Biotech Layoff Tracker: Biogen, Eisai cut workers; Inovio restructures
- The top 10 generic drug makers by 2021 revenue
The Top Line is produced by senior multimedia producer Teresa Carey with editor-in-chief Tracy Staton, managing editor Querida Anderson and senior editors Annalee Armstrong, Ben Adams, Conor Hale and Eric Sagonowsky. The sound engineer is Caleb Hodgson. The stories are by all our “Fierce” journalists. Like and subscribe wherever you listen to your podcasts.
See omnystudio.com/listener for privacy information.
Biopharma watchers have been speculating for weeks about Merck & Co. buying out fellow cancer drugmaker Seagen. But now, the two companies are reportedly nearing a deal. We'll discuss how it could be the largest biopharma deal since 2020—and what might stand in its way.
But that's not all. Every year Fierce puts together a special report ranking the highest-paid biopharma CEOs of the year – and this year is no different. We'll cover that, plus this week's headlines.
To learn more about the topics in this episode:
- Merck said to near $40B deal to buy Seagen. But will FTC rain on their parade?
- The 15 highest paid biopharma CEOs of 2021
- FDA lets pharmacists prescribe Pfizer's Paxlovid, easing access to the COVID antiviral
- FDA is letting pharmacists prescribe Pfizer's Paxlovid but won't do the same for Merck's Lagevrio
- 'Organize. Align': Women in biotech see Roe v. Wade ruling as a call to action
- SEC charges ex-Mazor exec with insider trading over $1.6B Medtronic buyout
- Game on, Hemlibra. Novo Nordisk's attempt to snatch Roche's hemophilia crown gets serious
The Top Line is produced by senior multimedia producer Teresa Carey with editor-in-chief Tracy Staton, managing editor Querida Anderson and senior editors Annalee Armstrong, Ben Adams, Conor Hale and Eric Sagonowsky. The sound engineer is Caleb Hodgson. The stories are by all our “Fierce” journalists. Like and subscribe wherever you listen to your podcasts.
See omnystudio.com/listener for privacy information.
FDA officials want to reform the agency's accelerated approvals program, but Paul Hastings, chair of one of biotech's leading trade organizations, has some thoughts. Reforms could limit innovation, Hastings argues, but data suggest the program could be improved. We'll discuss the tug and pull between regulators and businesses.
But that's not all. A Vertex Pharmaceuticals’ diabetes therapy is back on track. Two months ago the FDA placed a clinical hold on the drug, but now a trial is underway. And Orchestra BioMed has had a busy week with a SPAC deal and a Medtronic partnership. We'll cover that, plus this week's headlines.
To learn more about the topics in this episode:
- Orchestra BioMed cues up Medtronic partnership, $400M SPAC deal
- Vertex's Type 1 diabetes cell therapy heads back to clinic after FDA hold lifted
- Dyne another day: DMD therapy back on track after FDA lifts clinical hold
- Gun-shy on accelerated approvals, FDA will convene a 2nd expert panel meeting to reconsider Amylyx’s ALS candidate
- Biogen-Eisai go for another biomarker approval in Alzheimer's with lecanemab—and snag priority review
The Top Line is produced by senior multimedia producer Teresa Carey with editor-in-chief Tracy Staton, managing editor Querida Anderson and senior editors Annalee Armstrong, Ben Adams, Conor Hale and Eric Sagonowsky. The sound engineer is Caleb Hodgson. The stories are by all our “Fierce” journalists. Like and subscribe wherever you listen to your podcasts.
See omnystudio.com/listener for privacy information.
In preparation for the fall, FDA advisors resoundingly recommended that a component of the Omicron variant be added to future vaccine doses. But just what that new vaccine formula looks like will be up to the agency to decide. We'll discuss how the committee came to its decision and what the future holds. But thats not all. Two reports – one from Moody’s and the other from PwC – discuss the outlook for mergers and acquisitions in the biopharma industry. Both reports point to an uptick in activity in both the short and long term. We'll discuss what the report says regarding financial flexibility and why the time is right for an increase in deals.
To learn more about the topics in this episode:
- 'Science at its hardest': FDA panel recommends incorporating omicron variant into future COVID boosters
- Pfizer joins the omicron data party, linking adapted vaccine to increased immune response ahead of FDA meeting
- M&A is down, but Big Pharma likely to line up 'multiple shots on goal' in 2nd half, PwC says
- BMS, Pfizer and Merck face steep patent cliffs but all have the financial flexibility for M&A: Moody's
- Lundbeck, Otsuka to seek new FDA approval for Rexulti after it reduced agitation in Alzheimer's patents
- Clover's COVID booster bolsters antibody levels against omicron
- 'Leaner and simpler': Novartis details plans to cut 8,000 jobs worldwide
The Top Line is produced by senior multimedia producer Teresa Carey with editor-in-chief Tracy Staton, managing editor Querida Anderson and senior editors Annalee Armstrong, Ben Adams, Conor Hale and Eric Sagonowsky. The sound engineer is Caleb Hodgson. The stories are by all our “Fierce” journalists.
See omnystudio.com/listener for privacy information.
A Roche Genentech Alzheimer’s therapy failed an important clinical trial. At the press conference that followed, the scientists involved parsed over what when wrong and what should happen next. We'll discuss this conference and dive into what scientists are saying about an Alzheimer's moonshot. But that's not all. During a panel discussion at the BIO conference, a Fierce journalist witnessed a controversial take on a diversity—which led to a conversation on diversity in biotech. Lastly, we'll take a close look at the top winners in pharma, health and wellness at the Cannes Lions International Festival of Creativity.
To learn more about the topics in this episode:
- Will we ever land the Alzheimer's moonshot? Genentech's crenezumab partners reflect on failure
- Another knock back for amyloid: Roche's approach to presymptomatic Alzheimer's ends in failure
- BIO: 'Diversity candidates' and knowledge 'shortfalls': Women in biotech say 'I'm here to do my job' despite toxic tropes
- Bausch Health pulls the plug on Solta Medical IPO and 3-way company split
- FDA signs off on Pfizer, Moderna COVID-19 vaccines for kids 6 months and older
- Galapagos finally takes M&A plunge, spending $251M for 2 biotechs in CAR-T push
- Hot on Alnylam's heels, AstraZeneca racks up phase 3 win for Ionis-partnered rare disease drug
- Big Pharmas lose out at Cannes Lions as VMLY&R sweeps health categories with campaigns for Dell and Maxx Flash
- Winning agency behind Cannes Lions says its double health Grand Prix win shows a major shift in thinking
- Fierce Biotech NextGen Virtual Event
The Top Line is produced by senior multimedia producer Teresa Carey with editor-in-chief Tracy Staton, managing editor Querida Anderson and senior editors Annalee Armstrong, Ben Adams, Conor Hale and Eric Sagonowsky. The sound engineer is Caleb Hodgson. The stories are by all our “Fierce” journalists.
See omnystudio.com/listener for privacy information.
While revenue reflects how well a company’s products are selling, profit is the financial metric that really matters. It tells investors how efficiently a company is managed and how healthy the business is overall. We’ve taken a look at these bottom line figures and compiled a list of the top 10 most profitable pharma companies. But that's not all. The FDA advisory committee meeting met last Thursday and Friday, and the stakes were high. Bluebird bio came away on top. The committee endorsed two of its gene therapy candidates. Lastly, we’re all celebrating here at Fierce because our team’s faces are plastered on billboards at BIO International Convention. And we sent one shoe-leather reporter on a wild goose chase to find them.
To learn more about the topics in this episode:
- The top 10 most profitable pharma companies in 2021
- Pfizer already agreed to delay supply of COVID-19 shots to EU, now the bloc wants more
- GSK hails phase 3 win for RSV vaccine in older adults, sparking race to regulators
- Rune Labs translates Apple Watch data into Parkinson's insights with FDA nod
- Bluebird gene therapy overcomes safety worries to snag a win at FDA advisory panel
- Bluebird scores 2nd straight win at high-stakes FDA gene therapy meeting
- Amid FDA delay, Amylyx scores conditional ALS drug nod in Canada
- Eli Lilly's Olumiant snags biopharma's first FDA green light for alopecia areata
- Alnylam's next-gen RNA drug Amvuttra wins FDA approval—and a Pfizer showdown may await
- Ekso Bionics nabs FDA exoskeleton clearance for multiple sclerosis rehabilitation
- Pfizer gives up on Paxlovid in less vulnerable COVID patients after data fail to impress
The Top Line is produced by senior multimedia producer Teresa Carey with editor-in-chief Tracy Staton, managing editor Querida Anderson and senior editors Annalee Armstrong, Ben Adams, Conor Hale and Eric Sagonowsky. The sound engineer is Caleb Hodgson. The stories are by all our “Fierce” journalists.
See omnystudio.com/listener for privacy information.
Another ASCO and more CAR-T data. Arcellx presented early results on its multiple myeloma therapy at last weekend’s ASCO annual meeting, and we dig into what it would take to stand up to J&J's Carvykti. But that’s not all. People were on their feet for the Enhertu breast cancer drug and its unheard-of results. We’ve got a lot to share about ASCO. Also under discussion is Fierce's special report on the rising stars in the medtech and healthcare fields and what they have in common. Lastly, we finally have boots-on-the-ground at an industry conference. Our reporter headed out to the first in-person ASCO since the pandemic started. She planned to learn about new data releases and discoveries, and also found out something surprising about herself.
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To learn more about the topics in this episode:
- Fierce Healthcare and Fierce Medtech's 17 rising stars in health tech
- ASCO: AstraZeneca, Daiichi’s Enhertu could transform breast cancer treatment with landmark HER2-low show
- ASCO: Gilead's Trodelvy limps forward in new breast cancer lane as below-par showing casts doubt
- ASCO: ‘Any way you slice’ it, Arcellx's CAR-T is matching J&J-Legend’s Carvykti, analyst says
- ASCO: Medidata links CAR-T's cytokine release syndrome risk to common biomarkers in new study
- ASCO: Black breast cancer patients want to participate in trials, but adequate information is hard to come by
- Emergent says J&J owes up to $420M for breach of contract. J&J: You want to talk breaches?
- ADA: Eli Lilly's stellar tirzepatide weight loss data tee up showdown with Novo Nordisk's Wegovy, analysts say
- ADA: With promising long-term data for its artificial pancreas, Medtronic aims to fully close the diabetes management loop
- UPDATE: Bristol Myers strikes up Roche rivalry with $4.1B Turning Point buy
- Eli Lilly wins key dispute over patient warnings in era of DTC advertising
- ASCO: Return to in-person 'zoo that it always was,' with added COVID challenges—and bad shoes
The Top Line is produced by senior multimedia producer Teresa Carey with editor-in-chief Tracy Staton, managing editor Querida Anderson and senior editors Annalee Armstrong, Ben Adams, Conor Hale and Eric Sagonowsky. The sound engineer is Caleb Hodgson. The stories are by all our “Fierce” journalists.
See omnystudio.com/listener for privacy information.
Bristol Myers Squibb is once again piling on the cash for Immatics, a German immunotherapy biotech. The Big Pharma has tripled down on the collaboration, which originally kicked off in 2019 and was added to in 2021. BMS is paying $60 million upfront and $700 million in biobucks down the line for at least two new programs. And there's more: Bristol expanded the 2019 collaboration, with another $20 million plus milestones and royalties. Also under discussion is Fierce Pharma’s special report on the world’s 20 top-selling drugs. COVID-19 vaccines by Pfizer and Moderna are listed among the top three. And COVID treatments from Regeneron/Roche and Gilead were also in the top 20.
Lastly, we have bloopers. After just over a month of creating this podcast, we finally have some “behind-the-scenes" tape to share.
To learn more about the topics in this episode:
- The top 20 drugs by worldwide sales in 2021
- ASCO preview: How Gilead, Pfizer, AstraZeneca-Daiichi breast cancer data may—or may not—change treatment practice
- ASCO: Mirati cedes to Amgen's Lumakras on durability in tight KRAS battle
- SKYLARK sings: Sage, Biogen hatch positive phase 3 data in postpartum depression
- GSK strikes $3.3B Affinivax buyout to MAP out challenge to Pfizer's blockbuster pneumococcal vaccine
- Pfizer, already flush with cash, will reap $16B from selling shares in GSK consumer health spinoff
- Roche's Evrysdi ramps up SMA rivalry with Novartis and Biogen thanks to FDA nod in newborns
- Novartis' Kymriah bags FDA nod to face off against Gilead's Yescarta in follicular lymphoma
- UPDATE: Bristol Myers triples-down on Immatics, bringing deal to $4.2B total biobucks. Why not just buy it?
The Top Line is produced by senior multimedia producer Teresa Carey with editor-in-chief Tracy Staton, managing editor Querida Anderson and senior editors Annalee Armstrong, Ben Adams, Conor Hale and Eric Sagonowsky. The sound engineer is Caleb Hodgson. The stories are by all our “Fierce” journalists.
See omnystudio.com/listener for privacy information.
When unnamed Bloomberg sources said that Dexcom is in talks to buy Insulet in what could be the year's biggest medtech megamerger, stock prices went wild. And the American Society for Clinical Oncology annual meeting, the biggest cancer conference, will be held in June, but we have early news to share. Also under discussion is the new monkeypox outbreak, what the treatment options are and why health officials don’t seem concerned. Lastly, nominations are finally open for the annual Fierce 15 competition. We'll hear from the judges about what it takes to make your nomination stand out from the rest.
To learn more about the topics in this episode:
- Roche rolls out trio of PCR research tests for monkeypox
- Bavarian Nordic signs 'larger' monkeypox vaccine supply deal with unnamed country
- US to provide Bavarian Nordic's vaccine Jynneos to some at risk for monkeypox, CDC says
- Moderna tunes vaccine platform to next potential viral threat: monkeypox
- Monkeypox outbreak won't be the next global pandemic thanks to vaccines, drugs: analysts
- Dexcom, Insulet in talks to merge into a diabetes device behemoth: report
- Biohaven flunks first clinical test for rare disease drug post-Pfizer sell-off
- ASCO: Is another pan-tumor drug on the horizon? Johnson & Johnson thinks Balversa could be it
- ASCO: J&J, Legend reveal more CAR-T data and a look at Carvykti for earlier myeloma in a difficult population
- ASCO: J&J's multiple myeloma toolkit expands with bispecifics data
- ASCO: Novartis eyes full nod for Gleevec follow-on Scemblix thanks to new leukemia data
- GSK dodges UK strike with improved pay offer for staffers
- Calling all Fierce 15 fans: Nominations for the 2022 Fierce Biotech Fierce 15 are now open
The Top Line is produced by senior multimedia producer Teresa Carey with editor-in-chief Tracy Staton, managing editor Querida Anderson and senior editors Annalee Armstrong, Ben Adams, Conor Hale and Eric Sagonowsky. The sound engineer is Caleb Hodgson. The stories are by all our “Fierce” journalists.
See omnystudio.com/listener for privacy information.
Anti-TIGIT drugs were once hailed as the future of immuno-oncology. But Roche's two recent clinical trial failures for tiragolumab are raising questions about whether Big Pharmas bet on the wrong horse. Also under discussion is the sector's impressive first-quarter revenue growth. Out of nearly two dozen biopharma companies, more than half generated double-digit growth, including eye-popping increases from mRNA stars Moderna and BioNTech. And Fierce journalists finally got together in person after more than two years. They share what it was like to be in a newsroom once again.
To learn more about the topics in this episode:
- To TIGIT or not to TIGIT? Roche's latest trial flop casts shadow on Big Pharma's $6B bet
- Roche's TIGIT flop prompts GSK, iTeos to reevaluate next steps for rival drug
- Strike 2: Roche flunks another phase 3 lung cancer test to leave TIGIT space reeling
- Pfizer, Merck and AstraZeneca led Big Pharma's growth in Q1 but they couldn't match mRNA hotshots
- Labcorp's combo COVID, flu, RSV test nabs first green light for direct-to-consumer
- Pfizer holding on tight to supplies of COVID-19 drug Paxlovid, limiting the prospect of combination research: report
- GlaxoSmithKline is no more: Meet the scaled down 'GSK'
- Avanos Medical faces Class I recall for feeding tube system linked to 23 deaths since 2015
- Lilly's highly anticipated diabetes drug Mounjaro wins FDA blessing
The Top Line is produced by senior multimedia producer Teresa Carey, with editor-in-chief Tracy Staton, managing editor Querida Anderson, senior editors Annalee Armstrong, Ben Adams, Conor Hale and Eric Sagonowsky. The sound engineer is Caleb Hodgson. The stories are by all our “Fierce” journalists.
See omnystudio.com/listener for privacy information.
Biotechs have seen their valuations take a plunge, triggering layoffs and pipeline cuts, but Big Pharma is not yet tempted to go on an M&A spree. CEOs of many of the world’s biggest pharma companies point out that biotech prices still have a way to drop before they become truly attractive buys. Also under discussion is Fierce's annual report on the highest paid biopharma R&D executives. This year, the list doesn’t look anything like it has in the past except for the fact that it continues to be comprised of white men. And the quarterly earnings calls are the buzz around the newsroom this week—but not in the way you might think.
To learn more about the topics in this episode:
- Big pharma resisting temptation for biotech M&A spree until prices drop further
- The top 10 highest paid biopharma R&D executives in 2021
- Novavax executives' pay comes back down to Earth after 8-figure package in 2020
- Starting gun? $11.6B M&A domino falls as Pfizer scoops up Biohaven for phase 3 migraine nasal spray
- Novartis halts US production of cancer radiotherapies, citing potential quality issues
- Eisai wraps filing for Biogen-partnered Aduhelm follow-up, hoping to regain 'credibility and trust'
- Illumina steps deeper into drug discovery with Deerfield, Janssen partnerships
- Seagen CEO Clay Siegall put on leave after domestic violence arrest
- Moderna's new CFO out the door after former employer discloses accounting probe
- Inovio CEO departs, leaving Jacqueline Shea in charge of 'particularly challenging period' in the DNA vaccine biotech's history
- Insulet to swap CEOs amid Omnipod 5 insulin pump rollout
- 'Who wants to make money?' Court documents outline wild fraud scheme targeting
The Top Line is produced by senior multimedia producer Teresa Carey with Editor-in-Chief Tracy Staton, Managing Editor Querida Anderson, senior editors Annalee Armstrong, Ben Adams, Conor Hale and Eric Sagonowsky. The sound engineer is Caleb Hodgson. The stories are by all our “Fierce” journalists.
See omnystudio.com/listener for privacy information.
Biogen has been battling for a while now over Aduhelm's controversial FDA approval and subsequent narrow Medicare coverage decision. And those struggles have resulted in a significant company reorganization, including the CEO, Michel Vounatsos. After a five-year term, he is stepping down, and a hunt for his replacement is already underway. Also under discussion is the Fierce newsroom's assessment of the most influential people in biopharma—from CEOs to entrepreneurs, scientists and regulatory experts. And the Fierce Madness drug naming championship is the buzz around the newsroom this week, with names that sound like they're straight out of a Harry Potter spell.
To learn more about the topics in this episode:
Biogen sends CEO to the exit, abandons Aduhelm sales team in $1B overhaul
Next Biogen CEO's most-prized expertise? Dealmaking experience, investors say
Biogen shoves Aduhelm to the side. It's time for lecanemab
Most influential people in biopharma—the CEOs
AbbVie's cystic fibrosis long-game doesn't pay off, as Galapagos med fails in triple combo
As superstar Revlimid fades faster than expected, BMS trims $600M from its 2022 sales projection
Abbott's COVID test sales reach all-time high—and maybe for the last time, the company says
As COVID testing cools, Thermo Fisher's biopharma services, clinical research revenues heat up
Hologic's M&A deals aim to pick up the torch from COVID testing sales
Siemens nearly doubles diagnostics forecast for the year amid renewed COVID testing surge
BD tightens up revenue guidance after completing Embecta diabetes spinoff
Bancel has 'never been as busy' amid M&A talks as Moderna preps for life after COVID
Unwelcome surprise for Vertex as FDA slaps hold on phase 1/2 diabetes cell therapy study
FDA plays tooth fairy, awards clearance to VideaHealth's cavity-spotting AI
Wherefore Tavneos? ChemoCentryx and the Brand Institute explain how the #FierceMadness winner got its name
ChemoCentryx’ Tavneos trounces BioMarin's Voxzogo to win #FierceMadness drug name tournament championship
The Top Line is produced by senior multimedia producer Teresa Carey, with editor-in-chief Tracy Staton, managing editor Querida Anderson, senior editors Annalee Armstrong, Ben Adams, Conor Hale and Eric Sagonowsky. The sound engineer is Caleb Hodgson. The stories are by all our “Fierce” journalists.
See omnystudio.com/listener for privacy information.
Last year, as the public made Pfizer, Johnson & Johnson, and Moderna household names, pharmaceutical companies took their cue. They poured more cash into unbranded campaigns compared to past years. Also under discussion this week is an intriguing executive move at Novartis. CEO Vas Narasimhan created a new position to oversee the company’s corporate strategy—then hired a high-profile Wall Street analyst to take the lead. And a journalist from Fierce Life Sciences heads to the Azbee Awards.
To learn more about the topics in this episode:
The top advertisers in Big Pharma
Novartis hires seasoned Wall Street analyst Ronny Gal as new M&A czar
Pfizer signals big M&A plans with new CFO Denton, the money manager behind the CVS-Aetna merger
Pfizer's blood pressure med recall creeps into US as testing flags carcinogen threat
Ardelyx's Hail Mary caught, as FDA agrees on appeal to convene advisory committee for tenapanor
Merck's C-suite shakeup logs another loss as marketing exec Garay leaves for Moderna
Nektar guts workforce, weeks after $3.6B Bristol Myers immuno-oncology collaboration ends
Abbott launches diabetes team-up with Ypsomed, CamDiab to bring artificial pancreas system to Europe
SURMOUNT-able: Lilly's tirzepatide clears high bar set by Novo's Wegovy in obesity
The Top Line is produced by senior multimedia producer Teresa Carey, with editor-in-chief Tracy Staton, managing editor Querida Anderson, senior editors Annalee Armstrong, Ben Adams, Conor Hale and Eric Sagonowsky. The sound engineer is Caleb Hodgson. The stories are by all our “Fierce” journalists.
See omnystudio.com/listener for privacy information.